WHO ICTRP trial
Study to determine if the investigational drug obeticholic acid (also known as…
EUCTR2018-002575-17-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-002575-17-FR |
|---|---|
| Public title | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). |
| Scientific title | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate… |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Czech… |
| Conditions | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 20.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class… |
| Interventions | Trade Name: Ocaliva 10mg 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 | Sep 7, 2019 |
| Target size | 54 |
| Secondary IDs | 747-213;2018-002575-17-HU |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: