WHO ICTRP trial
A clinical trial where neither the doctor, patient or sponsor know whether a…
EUCTR2017-001762-13-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-001762-13-ES |
|---|---|
| Public title | A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body. |
| Scientific title | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment |
| Primary sponsor | Intercept Pharmaceuticals, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes |
| Countries | United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany |
| Conditions | Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] |
| Interventions | Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other descriptive name: 6… |
| Registration date | Jun 20, 2018 |
| Target size | 50 |
| Secondary IDs | 747-401 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: