94. Primary sclerosing cholangitis Clinical trials / Disease details
Clinical trials : 148 / Drugs : 118 - (DrugBank : 39) / Drug target genes : 18 - Drug target pathways : 141
| 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 | EUCTR2022-002695-37-ES (EUCTR) | 13/02/2023 | 10/01/2023 | A study on safety and efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) | A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) | Adults patients with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor | Ipsen Bioscience, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Canada;United States;Italy;United Kingdom;France;Portugal;Germany;Spain | ||
| 2 | NCT05627362 (ClinicalTrials.gov) | January 27, 2023 | 22/11/2022 | A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. | A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC). | Primary Sclerosing Cholangitis | Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo Matched to Elafibranor 80 mg;Drug: Placebo Matched to Elafibranor 120 mg | Ipsen | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States |