93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
| 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 | EUCTR2022-001634-10-ES (EUCTR) | 23/01/2023 | 13/10/2022 | Study to Evaluate Safety, Tolerability and Efficacy in patients with Primary Biliary Cholangitis of Saroglitazar Magnesium-III (EPICS-III). | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis. - EPICS-III | Primary biliary Cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Saroglitazar Magnesium 1 mg INN or Proposed INN: SAROGLITAZAR MAGNESIUM Other descriptive name: SAROGLITAZAR MAGNESIUM Trade Name: Saroglitazar Magnesium 2 mg Product Name: Saroglitazar Magnesium 2 mg INN or Proposed INN: SAROGLITAZAR MAGNESIUM Other descriptive name: SAROGLITAZAR MAGNESIUM | Zydus Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 2;Phase 3 | United States;Argentina;Spain;Turkey;Iceland;Colombia;United Kingdom;Italy | ||
| 2 | NCT05133336 (ClinicalTrials.gov) | April 1, 2022 | 1/11/2021 | Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Saroglitazar Magnesium 1 mg;Drug: Saroglitazar Magnesium 2 mg;Drug: Placebo | Zydus Therapeutics Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 192 | Phase 2/Phase 3 | United States |
| 3 | NCT03112681 (ClinicalTrials.gov) | August 18, 2017 | 10/4/2017 | Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis | A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS ) | Primary Biliary Cirrhosis | Drug: Saroglitazar magnesium 2 mg;Drug: Saroglitazar magnesium 4 mg;Drug: Placebo Oral Tablet | Zydus Discovery DMCC | NULL | Active, not recruiting | 18 Years | 75 Years | All | 37 | Phase 2 | United States |