Rhpth (DrugBank: rhPTH)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 70 | 広範脊柱管狭窄症 | 1 |
| 235 | 副甲状腺機能低下症 | 29 |
| 326 | 大理石骨病 | 1 |
| 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 | EUCTR2011-006152-36-DK (EUCTR) | 10/05/2012 | 10/05/2012 | Does postoperative treatment with parathyroidea hormone Forteo®improve the disability inelderly patients undergoing spinal stabilization fusion surgery comparedwith patients treated with placebo. If that is the case, is there a correlationbetween improvement of disability and solid osseous healing? | Postoperative treatment with parathyroidea hormone Forteo® inpatients undergoing posterolateral spinal fusion surgery. A prospektiveand a randomized double-blinded, placebo-controlled study - PTH-U-DESE-STUDY | Spinal stenosis MedDRA version: 14.1;Level: LLT;Classification code 10041597;Term: Spinal stenosis of lumbar region;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Forteo Product Name: Forsteo Product Code: 0002-8971 INN or Proposed INN: teriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34) Other descriptive name: rhPTH (1-34) | Middelfart Rygsektor | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Denmark |
| 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 | NCT03878953 (ClinicalTrials.gov) | March 31, 2021 | 15/3/2019 | A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism | A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism | Chronic Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Not yet recruiting | 20 Years | 85 Years | All | 12 | Phase 3 | Japan |
| 2 | JPRN-JapicCTI-194828 | 31/3/2021 | 25/06/2019 | A Clinical Study of rhPTH (1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism | A Phase 3, Open-label Clinical Study of rhPTH (1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism | Chronic Hypoparathyroidism | Intervention name : rhPTH (1-84) INN of the intervention : Parathyroid hormone Dosage And administration of the intervention : rhPTH (1-84) will be administered at 25, 50, 75 and 100 micrograms once daily in one of the thighs (alternate thigh every day) as a subcutaneous injection. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | pending | 20 | 85 | BOTH | 12 | Phase 3 | Japan |
| 3 | NCT03364738 (ClinicalTrials.gov) | September 26, 2018 | 20/11/2017 | Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism | Hypoparathyroidism | Biological: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | N/A | All | 22 | Phase 3 | United States;Canada;Denmark;Hungary |
| 4 | EUCTR2017-003067-36-DK (EUCTR) | 08/08/2018 | 08/06/2018 | A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | Denmark;United States;Hungary;Canada | ||
| 5 | EUCTR2017-003067-36-HU (EUCTR) | 28/06/2018 | 25/04/2018 | A Study to Investigate the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism. | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: Human recombinant parathyroid Hormone Product Code: rhPTH(1-84) INN or Proposed INN: PARATHYROID HORMONE Other descriptive name: Parathyroid Hormone | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 3 | United States;Hungary;Canada;Denmark | ||
| 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 |
| 6 | EUCTR2017-000284-32-NL (EUCTR) | 04/06/2018 | 01/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;France;United States;Belgium;Spain;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 7 | EUCTR2017-000284-32-PT (EUCTR) | 02/04/2018 | 16/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpara Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | France;United States;Portugal;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2017-000284-32-BE (EUCTR) | 30/03/2018 | 18/12/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;France;United States;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 9 | NCT03324880 (ClinicalTrials.gov) | February 15, 2018 | 10/10/2017 | Study of the Effect of Recombinant Human Parathyroid Hormone [rhPTH(1-84)] on Symptoms Improvement and Metabolic Control Among Adults With Hypoparathyroidism | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism | Biological: rhPTH(1-84);Biological: Placebo | Shire | NULL | Recruiting | 18 Years | 85 Years | All | 150 | Phase 4 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom |
| 10 | EUCTR2017-000284-32-GB (EUCTR) | 05/02/2018 | 27/10/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with Recombinant Human Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | United States;Portugal;Spain;United Kingdom;Italy;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 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 |
| 11 | EUCTR2017-000284-32-SE (EUCTR) | 18/01/2018 | 02/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 12 | EUCTR2017-000284-32-DK (EUCTR) | 10/01/2018 | 09/11/2017 | Symptom Improvement Evaluation and Metabolic control among Adult Subjects with Symptomatic Hypoparathyroidism Treated with RecombinantHuman Parathyroid hormone [rhPTH(1-84)] | A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)] | Hypoparathyroidism MedDRA version: 20.0;Level: PT;Classification code 10051315;Term: Congenital hypoparathyroidism;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075900;Term: Primary hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) INN or Proposed INN: RECOMBINANT HUMAN PARATHYROID HORMONE (1-84) Other descriptive name: Parathyroid Hormone Trade Name: Natpar Product Name: human recombinant parathyroid hormone Product Code: rhPTH(1-84) | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3;Phase 4 | Portugal;United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 13 | NCT02824718 (ClinicalTrials.gov) | June 6, 2017 | 1/7/2016 | Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism | A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism | Autosomal Dominant Hypocalcemia or OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment | Drug: Teriparatide;Drug: Thiazide;Drug: Potassium sparing diuretic;Drug: Alfacalcidol | Assistance Publique - Hôpitaux de Paris | Ministry of Health, France | Recruiting | 18 Years | 80 Years | All | 12 | Phase 2 | France |
| 14 | NCT03150108 (ClinicalTrials.gov) | May 16, 2017 | 1/5/2017 | Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects | A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects | Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States |
| 15 | NCT02781844 (ClinicalTrials.gov) | April 3, 2017 | 19/4/2016 | Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism | An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism | Hypoparathyroidism | Drug: 25mcg rhPTH(1-84);Drug: 50mcg rhPTH(1-84);Drug: 100mcg rhPTH(1-84) | Shire | NULL | Completed | 18 Years | N/A | All | 34 | Phase 1 | United States;Canada;Denmark;Hungary |
| 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 |
| 16 | NCT02910466 (ClinicalTrials.gov) | December 9, 2016 | 20/9/2016 | A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism | A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism | Chronic Hypoparathyroidism;Hypoparathyroidism | Drug: rhPTH(1-84) | Shire | NULL | Completed | 18 Years | 85 Years | All | 36 | Phase 4 | United States |
| 17 | EUCTR2016-000500-29-FR (EUCTR) | 03/06/2016 | 26/04/2016 | A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia | A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia - ACTICAS | Autosomal dominant hypocalcemia (ADH) MedDRA version: 19.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: FORSTEO-R Product Name: FORSTEO-R INN or Proposed INN: Tériparatide Other descriptive name: FORSTEO-R Trade Name: ESIDREX-R 25 mg Product Name: ESIDREX-R 25 mg INN or Proposed INN: Hydrochlorothiazide Other descriptive name: ESIDREX-R Trade Name: UN-ALPHA-R 0.25µg Product Name: UN-ALPHA-R 0.25µg INN or Proposed INN: Alfacalcidol Other descriptive name: UN-ALPHA-R | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | France | ||
| 18 | NCT01455181 (ClinicalTrials.gov) | August 19, 2011 | 15/9/2011 | A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary | A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 24 | Phase 3 | Hungary |
| 19 | EUCTR2011-001265-40-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with Hypoparathyroidism | A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults with Hypoparathyroidism - A Clinical Extension Study - Not applicable | Hypoparathyroidism MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Hungary | |||
| 20 | NCT01297309 (ClinicalTrials.gov) | April 6, 2011 | 11/2/2011 | A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE) | A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE) | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 51 | Phase 3 | United States |
| 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 |
| 21 | NCT01268098 (ClinicalTrials.gov) | January 2011 | 28/12/2010 | Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY) | A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism | Hypoparathyroidism | Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 42 | Phase 3 | United States |
| 22 | EUCTR2008-005063-34-LT (EUCTR) | 29/11/2010 | 16/08/2010 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Trade Name: PREOTACT Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 23 | EUCTR2008-005063-34-HU (EUCTR) | 27/09/2010 | 04/10/2010 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.1;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 24 | EUCTR2008-005063-34-FR (EUCTR) | 14/09/2009 | 14/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 9.1;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 25 | EUCTR2008-005063-34-DK (EUCTR) | 27/08/2009 | 17/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 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 |
| 26 | EUCTR2008-005063-34-GB (EUCTR) | 04/08/2009 | 22/05/2009 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 13.0;Level: PT;Classification code 10021041;Term: | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;Hungary;Belgium;Lithuania;Denmark;Italy;United Kingdom | |||
| 27 | EUCTR2008-005063-34-IT (EUCTR) | 27/04/2009 | 18/06/2009 | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040 | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - CL1-11-040 | Hypoparatthyroidism MedDRA version: 12.0;Level: LLT;Classification code 10021041;Term: Hypoparathyroidism | Product Code: NPSP 558 Product Code: NPSP 558 Product Code: NPSP 558 | NPS PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Hungary;United Kingdom;Belgium;Denmark;France;Italy;Lithuania | ||
| 28 | NCT00732615 (ClinicalTrials.gov) | December 2008 | 8/8/2008 | Use of NPSP558 in the Treatment of Hypoparathyroidism | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism | Hypoparathyroidism | Drug: Placebo;Drug: NPSP558 | Shire | NULL | Completed | 18 Years | 85 Years | All | 124 | Phase 3 | United States;Belgium;Canada;Denmark;France;Hungary;Italy;United Kingdom |
| 29 | EUCTR2008-005063-34-BE (EUCTR) | 18/11/2008 | 18/11/2008 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP 558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)] for the Treatment of Adults with Hypoparathyroidism - Not applicable | Hypoparathyroidism MedDRA version: 12.0;Level: PT;Classification code 10021041;Term: | Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE Product Name: Rcombinant Human Parathyroid Hormone [rhPTH(1-84)] Product Code: NPSP 558 INN or Proposed INN: Parathyroid Hormone Other descriptive name: PARATHYROID HORMONE | NPS Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Lithuania;Denmark;Italy;United Kingdom;France;Hungary;Belgium |
| 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 | NCT00145886 (ClinicalTrials.gov) | February 2003 | 1/9/2005 | rhPTH Therapy for Low Turnover Bone Fragility | Effect of 12 Months Treatment With rhPTH on Calcium Balance, Bone Turnover, Bone Mineral Density, and Bone Micro-architecture in Patients With Fractures Associated With Low Bone Turnover and Sclerosing Bone Disorders | Osteopetrosis | Drug: rhPTH | University of Chicago | NULL | Terminated | 20 Years | N/A | Both | 2 | Phase 1 | United States |