94. 原発性硬化性胆管炎 ［臨床試験数：68，薬物数：72（DrugBank：31），標的遺伝子数：17，標的パスウェイ数：121］
Searched query = "Primary sclerosing cholangitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03678480 | March 1, 2021 | 11 March 2019 | A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC) | A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;Adolescent | Drug: HTD1801;Drug: Ursodeoxycholic Acid | HighTide Biopharma Pty Ltd | Not recruiting | 12 Years | 17 Years | All | 104 | Phase 2 | ||
| 2 | NCT04133792 | May 15, 2020 | 4 November 2019 | Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) | Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study | Primary Sclerosing Cholangitis | Drug: Simvastatin 40mg;Drug: Placebo oral tablet | Annika Bergquist | Not recruiting | 18 Years | 75 Years | All | 700 | Phase 3 | ||
| 3 | NCT04060147 | October 17, 2019 | 4 November 2019 | Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis | A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis | Primary Sclerosing Cholangitis;Compensated Cirrhosis | Drug: CILO | Gilead Sciences | Recruiting | 18 Years | 70 Years | All | 20 | Phase 1 | United States | |
| 4 | NCT04024813 | August 15, 2019 | 11 November 2019 | A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC | A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Seladelpar;Drug: Placebo to match Seladelpar | CymaBay Therapeutics, Inc. | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States;Canada;Poland | |
| 5 | NCT03710122 | June 2019 | 11 June 2019 | Vancomycin for Primary Sclerosing Cholangitis | A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Vancomycin;Other: Placebo | Elizabeth Carey | Arizona State University | Recruiting | 18 Years | 75 Years | All | 102 | Phase 2/Phase 3 | United States;Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03722576 | June 2019 | 11 June 2019 | Vidofludimus Calcium for Primary Sclerosing Cholangitis | Investigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Vidofludimus calcium | Elizabeth Carey | Arizona State University | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States |
| 7 | NCT03890120 | March 27, 2019 | 4 November 2019 | Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Cilofexor;Drug: Placebo | Gilead Sciences | Recruiting | 18 Years | 70 Years | All | 400 | Phase 3 | United States;Australia;Canada;Israel;Japan;New Zealand;Spain;Switzerland | |
| 8 | NCT02997878 | December 7, 2018 | 25 February 2019 | A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH | An Adaptive,Multicentre, Phase IIa, Multi-disease Trial Investigating the Safety & Activity of a Single Infusion of Selected Mesenchymal Stromal Cells in the Treatment of Patients With Primary Sclerosing Cholangitis & Autoimmune Hepatitis | Cholangitis, Sclerosing;Hepatitis, Autoimmune | Biological: Orbcel-C | University of Birmingham | European Union;NHS Blood and Transplant | Recruiting | 18 Years | 70 Years | All | 56 | Phase 1/Phase 2 | United Kingdom |
| 9 | NCT02780752 | October 2018 | 15 April 2019 | A Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis | A Pilot Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: hymecromone | Stanford University | Not recruiting | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States | |
| 10 | NCT03561584 | July 1, 2018 | 21 January 2019 | Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis | A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Sulfasalazine;Drug: Placebo | Brigham and Women's Hospital | Recruiting | 15 Years | 80 Years | All | 42 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03359174 | May 29, 2018 | 15 July 2019 | An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis | An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis | Cholangitis, Sclerosing | Drug: All-trans retinoic acid | Yale University | Recruiting | 18 Years | 80 Years | All | 20 | Phase 2 | United States | |
| 12 | NCT03333928 | February 9, 2018 | 11 November 2019 | A POC and Dose-Ranging Study of HTD1801 in PSC Patients | A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) | Drug: HTD1801;Drug: Placebo | HighTide Biopharma Pty Ltd | Recruiting | 18 Years | 75 Years | All | 90 | Phase 2 | United States | |
| 13 | NCT03872921 | February 8, 2018 | 4 November 2019 | norUrsodeoxycholic Acid vs Placebo in PSC | Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: norUrsodeoxycholic Acid | Dr. Falk Pharma GmbH | Recruiting | 16 Years | 75 Years | All | 300 | Phase 3 | Austria;Germany | |
| 14 | NCT03394781 | January 22, 2018 | 29 July 2019 | A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) | A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: DUR-928 | Durect | Not recruiting | 18 Years | 80 Years | All | 5 | Phase 2 | United States | |
| 15 | EUCTR2014-001438-27-ES | 29/11/2017 | 5 June 2018 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip Pharmaceutical Form: Coated tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Academic Medical Center | Authorised | Female: yes Male: yes | 84 | Phase 2 | Spain;Netherlands | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2016-003367-19-DE | 28/09/2017 | 30 April 2019 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid Pharmaceutical Form: Capsule INN or Proposed INN: Norursodeoxycholic acid CAS Number: 99697-24-2 Current Sponsor code: NorUDCA Other descriptive name: NorUDCA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Authorised | Female: yes Male: yes | 300 | Phase 3 | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 17 | NCT03216876 | September 2017 | 16 December 2017 | A Study Of Ursolic Acid For Primary Sclerosing Cholangitis | An Open-Label Study Of Ursolic Acid For Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Ursolic acid | University of California, Davis | Not recruiting | 18 Years | 70 Years | All | 0 | Phase 1 | United States | |
| 18 | NCT04006886 | July 11, 2017 | 15 July 2019 | Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) | Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study | Reduction of Intestinal Inflammatory Activity | Dietary Supplement: Gluten-free diet | Universitätsklinikum Hamburg-Eppendorf | Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel;Johannes Gutenberg University Mainz | Not recruiting | 18 Years | 65 Years | All | 17 | N/A | Germany |
| 19 | NCT02978339 | June 9, 2017 | 1 April 2019 | A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis | An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Curcumin | John E. Eaton | EuroPharma, Inc. | Not recruiting | 18 Years | 75 Years | All | 15 | Phase 1/Phase 2 | United States |
| 20 | NCT03099603 | March 24, 2017 | 16 December 2017 | A Study of HTD1801 in Healthy Subjects | A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects | Primary Sclerosing Cholangitis | Drug: HTD1801 | HighTide Biopharma Pty Ltd | Not recruiting | 18 Years | 50 Years | All | 32 | Phase 1 | Australia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03516006 | January 2017 | 11 June 2018 | Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: UCMSC;Drug: UDCA | Fuzhou General Hospital | Not recruiting | 18 Years | 65 Years | All | 20 | Phase 1/Phase 2 | ||
| 22 | NCT03046901 | December 7, 2016 | 8 April 2019 | Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients | Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients | Primary Sclerosing Cholangitis;Post- Orthotopic Liver Transplantation | Drug: Vancomycin | Ochsner Health System | Not recruiting | N/A | N/A | All | 0 | N/A | United States | |
| 23 | NCT02943460 | November 29, 2016 | 26 August 2019 | Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis | A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Subjects With Primary Sclerosing Cholangitis Without Cirrhosis | Primary Sclerosing Cholangitis | Drug: Cilofexor;Drug: Placebo to match Cilofexor | Gilead Sciences | Not recruiting | 18 Years | 70 Years | All | 52 | Phase 2 | United States;Austria;Canada;United Kingdom | |
| 24 | JPRN-UMIN000022897 | 2016/07/15 | 2 April 2019 | Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis | Primary sclerosing cholangitis | RItuximab induction for liver transplantation | Keio University Hospital | Recruiting | 2years-old | 65years-old | Male and Female | 10 | Not selected | Japan | ||
| 25 | EUCTR2015-003392-30-GB | 18/04/2016 | 30 April 2019 | The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC) | A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC) | PRIMARY SCLEROSING CHOLANGITIS (PSC) MedDRA version: 19.0 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0 Level: HLT Classification code 10004607 Term: Bile duct infections and inflammations System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0 Level: PT Classification code 10008609 Term: Cholangitis sclerosing System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0 Level: HLGT Classification code 10004606 Term: Bile duct disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NGM282 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: engineered recombinant human FGF19 CAS Number: 1616639-03-2 Current Sponsor code: NGM282 Other descriptive name: rec-h-FGF19 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: NGM282 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: engineered recombinant human FGF19 CAS Number: 1616639-03-2 Current Sponsor code: NGM282 Other descriptive name: rec-h-FGF19 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | NGM Biopharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Netherlands;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | JPRN-UMIN000021411 | 2016/04/01 | 7 October 2019 | clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis | clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis - clinical efficacy of oral administration of metronidazole in the treatment of PSC | primary sclerosing cholangitis | Patients take metronidazole 250mg orally three times day for 3 weeks. | Keio University, School of Medicine | Not Recruiting | 16years-old | Not applicable | Male and Female | 20 | Not applicable | Japan | |
| 27 | NCT02653625 | March 14, 2016 | 8 January 2018 | PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing Cholangitis | PERSEUS: A Phase 2 Proof of Concept Study Investigating the Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Cenicriviroc 150 mg | Tobira Therapeutics, Inc. | Not recruiting | 18 Years | 75 Years | All | 24 | Phase 2 | United States;Canada | |
| 28 | NCT02704364 | March 2016 | 20 August 2018 | Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis | A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Biological: NGM282;Other: Placebo | NGM Biopharmaceuticals, Inc | Not recruiting | 18 Years | 75 Years | All | 62 | Phase 2 | United States;France;Netherlands;United Kingdom | |
| 29 | NCT02424175 | February 1, 2016 | 9 September 2019 | Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis. | Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis. | Sclerosing Cholangitis | Biological: Fecal Microbiota Transplantation | Brigham and Women's Hospital | Not recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States | |
| 30 | NCT02701166 | February 2016 | 11 April 2016 | The Effect of Bezafibrate on Cholestatic Itch | The Effect of Bezafibrate on Cholestatic Itch | Primary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing Cholangitis | Drug: Bezafibrate;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico Humanitas | Recruiting | 18 Years | N/A | Both | 84 | Phase 3 | Netherlands;Spain |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03069976 | January 2016 | 23 April 2019 | Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children | Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in Children | Primary Sclerosing Cholangitis;Autoimmune Hepatitis;Overlap Syndrome | Drug: Metronidazole | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Recruiting | 3 Years | 25 Years | All | 20 | N/A | Belgium | |
| 32 | EUCTR2014-002205-38-IT | 02/12/2015 | 26 February 2018 | A Study of Obeticholic Acid (OCA) in Patients with Primary Sclerosing Cholangitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis - AESOP (Assessment of Efficacy and Safety of OCA in PSC) | Primary Sclerosing Cholangitis MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1,5 mg Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: ACIDO OBETICOLICO CAS Number: 459789-99-2 Current Sponsor code: OCA Other descriptive name: ACIDO OBETICOLICO Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: OCA 5 mg Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: ACIDO OBETICOLICO CAS Number: 459789-99-2 Current Sponsor code: OCA Other descriptive name: ACIDO OBETICOLICO Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | INTERCEPT PHARMACEUTICALS INC. | Authorised | Female: yes Male: yes | 75 | Phase 2 | United States;Italy | |||
| 33 | EUCTR2015-003310-24-SE | 09/10/2015 | 19 October 2015 | Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) | A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) - UDCAPSCSURV | Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Ursofalk Product Name: Ursofalk Pharmaceutical Form: Capsule, hard | Sahlgrenska Academy | Authorised | Female: yes Male: yes | Phase 3 | Sweden | ||||
| 34 | NCT02239211 | September 8, 2015 | 13 May 2019 | A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis | A Single Arm, Two-stage, Multi-centre, Phase II Clinical Trial Investigating the Safety and Activity of the Use of BTT1023 Targeting Vascular Adhesion Protein (VAP-1), in the Treatment of Patients With Primary Sclerosing Cholangitis (PSC). | Primary Sclerosing Cholangitis | Drug: BTT1023 | University of Birmingham | Biotie Therapies Corp.;University Hospital Birmingham;National Institute for Health Research, United Kingdom | Not recruiting | 18 Years | 75 Years | All | 23 | Phase 2 | United Kingdom |
| 35 | NCT02605213 | September 2015 | 23 November 2015 | Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients | Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis. | Primary Sclerosing Cholangitis | Drug: Vancomycin;Drug: Placebo | Tehran University of Medical Sciences | Recruiting | 18 Years | 60 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2014-001438-27-NL | 19/08/2015 | 14 September 2015 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Academic Medical Center | Authorised | Female: yes Male: yes | 84 | Netherlands | ||||
| 37 | NCT02464020 | July 2015 | 23 April 2019 | A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis | A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis;Inflammatory Bowel Disease | Drug: Vancomycin | University of Minnesota - Clinical and Translational Science Institute | Not recruiting | 18 Years | 80 Years | All | 8 | Phase 1 | United States | |
| 38 | NCT02061540 | March 2014 | 1 April 2019 | Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis | A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: LUM001 | Mirum Pharmaceuticals, Inc. | Not recruiting | 18 Years | 80 Years | All | 27 | Phase 2 | United States;Canada;United Kingdom | |
| 39 | JPRN-UMIN000012782 | 2014/02/01 | 2 April 2019 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Group A; phenylbutyrate 6g (Child 100mg/kg)/day *7days Group B; phenylbutyrate 6g (Child 100mg/kg)/day *3days and 12g (Child 200mg/kg)/day *4days Group C; phenylbutyrate 6g (Child 100mg/kg)/day *1day, phenylbutyrate 12g (Child 200mg/kg)/day *2days and phenylbutyrate 21g (Child 300mg/kg)/day *4days | Juntendo University | Not Recruiting | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan | ||
| 40 | NCT01879735 | June 2013 | 19 October 2017 | Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT | Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT | Cholestasis;Primary Sclerosing Cholangitis;Primary Biliary Cirrhosis | Drug: 11C-CSar;Drug: ICG | University of Aarhus | Not recruiting | 18 Years | N/A | All | 22 | Phase 1 | Denmark | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2009-018034-11-SE | 29/04/2013 | 3 June 2013 | Open pilot study of treatment with an antibiotic called vancomycin to children and adolescents with chronic inflammation of the bile ducts, called primary sclerosing cholangitis (PSC) | Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis - vanco-psc | Primary Sclerosing Cholangitis (PSC) is a progressive disease of the biliary system which might lead to increased risk of cholangiocancer. PSC constitutes a common indication for adult liver transplantation (ltx). In 80% of cases PSC is associated with inflammatory bowel disease (IBD), while 3-5 % of patients with colonic IBD, suffer from the disease. The conservative treatment options are few. There is a relatively high risk of recurrency after ltx.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Vancomycin Product Name: vancomycin Pharmaceutical Form: Capsule Trade Name: vancomycin Product Name: Vancomycin Pharmaceutical Form: Oral solution | Karolinska Institutet | Authorised | Female: yes Male: yes | 20 | Sweden | ||||
| 42 | NCT01672853 | February 2013 | 16 December 2017 | Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Subjects With Primary Sclerosing Cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) | Biological: Simtuzumab;Biological: Placebo | Gilead Sciences | Not recruiting | 18 Years | 70 Years | All | 235 | Phase 2 | United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom | |
| 43 | EUCTR2012-004170-26-IT | 04/12/2012 | 2 June 2014 | Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis. | Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis. | Chronic pancreatitis and primary sclerosing cholangitis MedDRA version: 15.0 Level: PT Classification code 10033649 Term: Pancreatitis chronic System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0 Level: PT Classification code 10008609 Term: Cholangitis sclerosing System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: FLUIMUCIL*20CPR EFF 600MG Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Pharmaceutical form of the placebo: Effervescent tablet Route of administration of the placebo: Oral use | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | Not Recruiting | Female: yes Male: yes | 200 | Italy | ||||
| 44 | NCT01755507 | December 2012 | 15 August 2016 | Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis | Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: norUDCA;Drug: Placebo | Dr. Falk Pharma GmbH | Not recruiting | 18 Years | 80 Years | Both | 159 | Phase 2 | Austria;Germany;Norway | |
| 45 | EUCTR2011-002754-31-NO | 13/11/2012 | 28 February 2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 14.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid Pharmaceutical Form: Capsule INN or Proposed INN: norursodeoxycholic acid CAS Number: 99697-24-2 Other descriptive name: NorUDCA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT01688024 | September 2012 | 19 September 2016 | Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis | Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Mitomycin C;Drug: Normal saline | Li, Zhiping, M.D. | Johns Hopkins University | Recruiting | 18 Years | N/A | Both | 130 | Phase 2 | United States |
| 47 | EUCTR2011-002754-31-DE | 02/08/2012 | 25 January 2016 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 18.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid Pharmaceutical Form: Capsule INN or Proposed INN: norursodeoxycholic acid CAS Number: 99697-24-2 Other descriptive name: NorUDCA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | |||
| 48 | NCT01695174 | August 2012 | 19 February 2015 | A Pilot Study of Xifaxan to Treat Patients With PSC | A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: Xifaxan | Mayo Clinic | Not recruiting | 18 Years | 75 Years | Both | 16 | Phase 1 | United States | |
| 49 | JPRN-UMIN000029482 | 2012/04/01 | 2 April 2019 | Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - | Primary sclerosing cholangitis | Administration of mizoribine and azathioprine | Osaka General Medical Center | Not Recruiting | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| 50 | JPRN-jRCTs051180120 | 01/04/2012 | 2 April 2019 | Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitis | Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis Study of the mizoribine and azathioprine combination immunosuppressive therapy - Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis | Primary sclerosing cholangitis; PSC | 1 MZR Daily intake of mizoribine once before breakfast. Dose adjustment is done to achieve a blood concentration level over 3.0 microg/ml at 3 hour after meal. 2)AZT Daily intake of azathioprine once after breakfast and once after dinner. Starting dose is 0.5-1.0mg/kg daily (max 2.0mg) , is increased according to the condition of patients. Dose is adjusted to achieve WBC 3000-5000/m3, neutrophils 2000-3500/m3(the dose of 6MP is appotoimatery half of azathioprine). Continue the dosage during a study period. | Hitoshi Tajiri | Recruiting | 3 | 18 | Both | 10 | Phase 2 | none | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT01549795 | January 2012 | 19 February 2015 | Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy | Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante | Hilar Cholangiocarcinoma;Primary Sclerosing Cholangitis | Procedure: Liver transplantation;Radiation: 45 Gy external radiations;Radiation: Endoluminal bile duct Brachytherapy;Drug: Capecitabine;Procedure: Pre liver transplantation laparoscopic hand assisted staging | Azienda Ospedaliera di Padova | Recruiting | 18 Years | 65 Years | Both | 33 | N/A | Italy | |
| 52 | NCT01802073 | January 2012 | 16 December 2017 | Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects | Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects | Primary Sclerosing Cholangitis | Drug: Oral Vancomycin | Stanford University | Not recruiting | 1 Year | N/A | All | 40 | Phase 3 | United States | |
| 53 | NCT01456468 | October 2011 | 8 August 2016 | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot Study | Cholangitis, Sclerosing | Drug: Oral all-trans retinoic acid (ATRA) | Yale University | Mayo Clinic | Not recruiting | 18 Years | 80 Years | Both | 19 | Phase 1 | United States |
| 54 | NCT01088607 | October 2010 | 16 December 2017 | Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis | Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution Trial | Primary Sclerosing Cholangitis | Drug: ursodeoxycholic acid (UDCA) | University of Tennessee | Icahn School of Medicine at Mount Sinai;Ann & Robert H Lurie Children's Hospital of Chicago;University of Colorado, Denver;University of California, San Francisco;University of Pittsburgh;Phoenix Children's Hospital;Children's Hospital of Philadelphia;Children's Healthcare of Atlanta;Children's Hospital Los Angeles;Texas Children's Hospital;Yale University | Not recruiting | 5 Years | 21 Years | All | 27 | Phase 1 | United States;Canada |
| 55 | NCT01142323 | October 2010 | 12 February 2018 | Pilot Study of Fenofibrate for PSC | Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: fenofibrate | University of Miami | University of Florida | Not recruiting | 18 Years | 75 Years | All | 8 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT02137668 | July 2010 | 21 November 2016 | Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | Primary Sclerosing Cholangitis;Biliary Atresia | Drug: Oral Vancomycin | Sacramento Pediatric Gastroenterology | Recruiting | N/A | 40 Years | Both | 200 | Phase 1 | United States | |
| 57 | JPRN-UMIN000003802 | 2010/04/01 | 2 April 2019 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | phenylbutyrate(Child 250mg/kg/day)for 1-4months : phenylbutyrate(Child 350mg/kg/day)for 1-4months : phenylbutyrate(Child 500mg/kg/day)for 1-4months | Saiseikai Yokohama City Tobu Hospital | Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Tokyo) | Recruiting | Not applicable | Not applicable | Male and Female | 15 | Not selected | Japan | |
| 58 | NCT01085760 | February 2010 | 19 October 2017 | A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis | A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Vancomycin;Drug: Metronidazole | Mayo Clinic | PSC Partners Seeking a Cure Foundation | Not recruiting | 18 Years | 75 Years | All | 35 | Phase 1 | United States |
| 59 | NCT00955149 | August 2009 | 19 February 2015 | Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC) | An Open Label Pilot Trial of Erlotinib (Tarceva) in Primary Sclerosing Cholangitis With Trisomy 7 | Primary Sclerosing Cholangitis;Trisomy 7;Cholangiocarcinoma;Chemoprevention | Drug: Erlotinib (Tarceva) | Mayo Clinic | Genentech, Inc. | Not recruiting | 18 Years | N/A | Both | 6 | Phase 1 | United States |
| 60 | NCT01322386 | May 2007 | 19 October 2017 | Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin. | Primary Sclerosing Cholangitis;Biliary Atresia | Drug: Vancomycin | Stanford University | Not recruiting | 1 Month | 20 Years | All | 32 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT00953615 | April 2006 | 19 October 2017 | Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC) | Open Label, Phase II Investigation of Thalidomide for the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Thalidomide | Mayo Clinic | Celgene Corporation | Not recruiting | 18 Years | 72 Years | All | 1 | Phase 2 | United States |
| 62 | NCT00325013 | December 2005 | 23 March 2015 | Evaluation of DHA for the Treatment of PSC | Evaluation of Docosahexaenoic Acid (DHA) for the Treatment of Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis;Colitis | Drug: Docosahexaenoic Acid (DHA) | Beth Israel Deaconess Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 80 Years | Both | 10 | Phase 1 | United States |
| 63 | EUCTR2005-001454-24-LT | 08/06/2005 | 19 March 2012 | An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With: - Chronic viral hepatitis - Chronic alcoholic liver diseases without cirrhosis - Compensated alcoholic liver cirrhosis - Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver disease | An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With: - Chronic viral hepatitis - Chronic alcoholic liver diseases without cirrhosis - Compensated alcoholic liver cirrhosis - Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver disease | Chronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis MedDRA version: 1.1 Level: SOC Classification code 10019805 | Product Name: Cis-4-Hydroxy-L-Proline Product Code: 3108006977 Pharmaceutical Form: Oral powder | RIEMSER Arzneimittel AG | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Lithuania | |||
| 64 | NCT00161148 | January 2005 | 19 February 2015 | Probiotics in Patients With Primary Sclerosing Cholangitis | Probiotics in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Disease- a Randomized Placebo-Controlled Cross-Over Trial | Primary Sclerosing Cholangitis | Drug: Probiotics | UMC Utrecht | Recruiting | 18 Years | N/A | Both | 12 | Phase 3 | Netherlands | |
| 65 | NCT00059202 | April 2003 | 19 February 2015 | Trial of High-dose Urso in Primary Sclerosing Cholangitis | Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis | Sclerosing Cholangitis | Drug: Ursodeoxycholic Acid | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 75 Years | Both | 150 | Phase 2/Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT00630942 | February 2003 | 19 February 2015 | Minocycline in Primary Sclerosing Cholangitis (PSC) | Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Minocycline | Mayo Clinic | Not recruiting | 18 Years | 75 Years | Both | 16 | Phase 1 | United States | |
| 67 | NCT00004842 | May 1997 | 16 December 2017 | Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis | Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis | Cholangitis, Sclerosing;Liver Cirrhosis, Biliary | Drug: budesonide | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Mayo Clinic | Not recruiting | 18 Years | 70 Years | All | 22 | Phase 1 | United States |
| 68 | NCT00004762 | December 1994 | 19 February 2015 | Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis | Cholangitis, Sclerosing | Drug: cladribine | National Center for Research Resources (NCRR) | Scripps Clinic | Not recruiting | 18 Years | N/A | Both | 5 | Phase 2 |