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 | EUCTR2018-004011-44-GB (EUCTR) | 10/08/2020 | 28/05/2020 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus. - TURRIFIC Protocol Version 8 | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin. MedDRA version: 20.1;Level: PT;Classification code 10049055;Term: Cholestasis of pregnancy;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.1;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin INN or Proposed INN: Rifampicin Product Name: Ursodeoxycholic acid INN or Proposed INN: Ursodeoxycholic acid | The University Of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 3 | Finland;Australia;Netherlands;United Kingdom;Sweden | ||
| 2 | EUCTR2018-004011-44-FI (EUCTR) | 20/05/2020 | 26/09/2019 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritis. - TURRIFIC | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin Product Name: Ursodeoxycholic acid | The University of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 4 | Finland;Australia;Netherlands;United Kingdom;Sweden |