94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 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 | EUCTR2020-001428-33-NL (EUCTR) | 27/07/2021 | 31/08/2020 | A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis) | A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC) | Primary sclerosing cholangitis (PSC) 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: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established | Pliant Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | France;United States;Canada;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2020-001428-33-DE (EUCTR) | 15/02/2021 | 17/07/2020 | A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis) | A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC) | Primary sclerosing cholangitis (PSC) 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: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established | Pliant Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | France;United States;Canada;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2020-001428-33-BE (EUCTR) | 10/11/2020 | 23/07/2020 | A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis) | A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC) | Primary sclerosing cholangitis (PSC) 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: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: bexotegrast Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: bexotegrast | Pliant Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | France;United States;Canada;Belgium;Austria;Australia;Norway;Germany;Netherlands;United Kingdom | ||
| 4 | EUCTR2020-001428-33-GB (EUCTR) | 05/11/2020 | 22/06/2020 | A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis) | A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC) | Primary sclerosing cholangitis (PSC) 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: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not yet established | Pliant Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | United States;France;Canada;Belgium;Austria;Australia;Norway;Netherlands;Germany;United Kingdom | ||
| 5 | NCT04480840 (ClinicalTrials.gov) | July 27, 2020 | 13/7/2020 | Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC) | A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC) | Primary Sclerosing Cholangitis | Drug: PLN-74809;Drug: Placebo | Pliant Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;United Kingdom |