Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 September 2020 |
Main ID: |
EUCTR2018-002575-17-ES |
Date of registration:
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26/07/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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).
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Scientific title:
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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 Ursodeoxycholic Acid |
Date of first enrolment:
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15/10/2019 |
Target sample size:
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54 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002575-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Ireland
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Israel
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Korea, Republic of
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Latvia
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Lithuania
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Netherlands
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Norway
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Poland
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Slovakia
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Slovenia
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Pawel Waszka
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Address:
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1030 Sync Street
27560
Morrisville, North Carolina
United States |
Telephone:
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+48222564220 |
Email:
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pawel.waszka@syneoshealth.com |
Affiliation:
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Syneos Health |
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Name:
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Pawel Waszka
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Address:
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1030 Sync Street
27560
Morrisville, North Carolina
United States |
Telephone:
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+48222564220 |
Email:
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pawel.waszka@syneoshealth.com |
Affiliation:
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Syneos Health |
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Key inclusion & exclusion criteria
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Inclusion criteria: - A definite or probable diagnosis of PBC (consistent with the European Association for the Study of the Liver [EASL] Practice Guidelines and the American Association for the Study of Liver Diseases; [Lindor 2009a, EASL 2017]) - Qualifying ALP and bilirubin liver biochemistry values - Age =18 years - Taking UDCA for at least 12 months (stable dose for =3 months) before Day 1 or unable to tolerate or unresponsive to UDCA (no UDCA for =3 months) before Day 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria: - History or presence of other concomitant liver diseases - Presence of clinical complications of PBC or clinically significant (CS) hepatic decompensation - Current or history of gallbladder disease with or without cholelithiasis - Severe renal failure (serum creatinine >1.5 mg/100 mL (>135 µmol/L); creatinine clearance <60 mL/min) or undergoing dialysis - Severe pruritus, or required systemic treatment for pruritus (eg, with bile acid sequestrants or rifampicin) within 2 months of Day 1 - History of known or suspected CS hypersensitivity to OCA, BZF, or other fibrates or any of their components - Was treated with commercially available OCA or participated in a previous study involving OCA within 1 year before Screening or plans to use commercially available OCA during the study - Is unable to tolerate BZF or other fibrates, was treated with commercially available fibrates or participated in a previous study involving fibrates within 3 months before Screening, or plans to use commercially available fibrates during the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 21.0
Level: LLT
Classification code 10036680
Term: Primary biliary cirrhosis
System Organ Class: 100000004871
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Intervention(s)
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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 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Trade Name: Ocaliva 5mg 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 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Trade Name: Bezalip Product Name: Bezafibrate IR Pharmaceutical Form: Tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Bezalip mono Product Name: Bezafibrate SR Pharmaceutical Form: Tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate ursodeoxycholic acid (UDCA).
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Timepoint(s) of evaluation of this end point: week 12
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Primary end point(s): Absolute change in ALP from baseline to Week 12 in the DB Treatment Period
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Secondary Objective: The secondary objectives are to assess the effects of the combination of OCA and BZF in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate UDCA on the following: - Safety and tolerability - Response and normalization rates of biochemical disease markers - Disease-specific symptoms as assessed by health-related quality of life questionnaires - Biomarkers of bile acid synthesis and homeostasis
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Baseline to End of study
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Secondary end point(s): - Safety and tolerability - Response and normalization rates of biochemical disease markers - Disease-specific symptoms as assessed by health-related quality of life questionnaires - Biomarkers of bile acid synthesis and homeostasis
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Secondary ID(s)
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2018-002575-17-HU
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747-213
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Source(s) of Monetary Support
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Intercept Pharmaceuticals, Inc.
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Ethics review
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Status: Approved
Approval date: 19/09/2019
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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