DDrare: Database of Drug Development for Rare Diseases

Searched query = "Primary sclerosing cholangitis", "PSC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 11C-CSar; 3108006977; ACETYLCYSTEINE; ACIDO OBETICOLICO; ATRA; AZT; Acetylcysteine; All-trans retinoic acid; Azathioprine; BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée; BEZAFIBRATE; BTT1023; BTT1023 IV Infusion 20 mg/mL, 5 mL Drug Product; Befizal; Bezafibrate; Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy; Bezalip; Budesonide; C10AB02; CILO; CM-101; Calcium; Capecitabine; Cenicriviroc; Cenicriviroc 150 mg; Cilofexor; Cis-4-Hydroxy-L-Proline; Cladribine; Curcumin; DHA; DUR-928; Docosahexaenoic Acid (DHA); Docosahexaenoic acid; Engineered recombinant human FGF19; Entyvio; Erlotinib; Erlotinib (Tarceva); FLUIMUCIL*20CPR EFF 600MG; Fecal Microbiota Transplantation; Fenofibrate; Fluimucil; GS-6624; GS-9674; Gluten-free diet; HTD1801; Humanised IgG1 monoclonal antibody against human eotaxin-2; Hymecromone; ICG; INT-747, OCA; LUM001; MBX-8025; MLN0002; Metronidazole; Minocycline; Mitomycin; Mitomycin C; Mizoribine; NGM282; NorUDCA; NorUrsodeoxycholic Acid; NorUrsodeoxycholic acid; Normal saline; Norursodeoxycholic acid; OCA; OCA 1,5 mg; OCA 5 mg; Oral Vancomycin; Oral all-trans retinoic acid (ATRA); Orbcel-C; PLN-74809; Phenylbutyrate; Probiotics; Procedure: Liver transplantation; Procedure: Pre liver transplantation laparoscopic hand assisted staging; Proline; Radiation: 45 Gy external radiations; Radiation: Endoluminal bile duct Brachytherapy; Rec-h-FGF19; Retinoic acid; Rituximab; SELADELPAR; Seladelpar; Simtuzimab; Simtuzumab; Simvastatin; Simvastatin 40mg; Sulfasalazine; TBC; Thalidomide; UCMSC; UDCA; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ursodeoxycholic acid (UDCA); Ursofalk; Ursolic acid; VEDOLIZUMAB; Vancomycin; Vedolizumab; Vedolizumab IV; Vidofludimus; Vidofludimus calcium; Volixibat; Xifaxan; [18F]FP-R01-MG-F2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03678480 (ClinicalTrials.gov)	March 1, 2021	18/9/2018	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	NULL	Not yet recruiting	12 Years	17 Years	All	104	Phase 2	NULL
2	EUCTR2015-003310-24-SE (EUCTR)	09/10/2015	01/09/2015	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	Sahlgrenska Academy	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Sweden
3	NCT01456468 (ClinicalTrials.gov)	October 2011	14/10/2011	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	Completed	18 Years	80 Years	Both	19	Phase 1	United States
4	NCT01088607 (ClinicalTrials.gov)	October 2010	12/3/2010	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	Completed	5 Years	21 Years	All	27	Phase 1	United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03678480
(ClinicalTrials.gov)

March 1, 2021

18/9/2018

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

NULL

Not yet recruiting

12 Years

17 Years

All

104

Phase 2

NULL

EUCTR2015-003310-24-SE
(EUCTR)

09/10/2015

01/09/2015

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

Sahlgrenska Academy

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Sweden

NCT01456468
(ClinicalTrials.gov)

October 2011

14/10/2011

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

Completed

18 Years

80 Years

Both

Phase 1

United States

NCT01088607
(ClinicalTrials.gov)

October 2010

12/3/2010

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

Completed

5 Years

21 Years

All

Phase 1

United States;Canada