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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: EUCTR
Last refreshed on: 28 September 2020
Main ID:  EUCTR2018-002575-17-ES
Date of registration: 26/07/2019
Prospective Registration: Yes
Primary sponsor: Intercept Pharmaceuticals, Inc.
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 Ursodeoxycholic Acid
Date of first enrolment: 15/10/2019
Target sample size: 54
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002575-17
Study type:  Interventional clinical trial of medicinal product
Study design:  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
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Australia Austria Belgium Croatia Czech Republic Denmark Estonia Finland
France Germany Greece Hungary Ireland Israel Korea, Republic of Latvia
Lithuania Netherlands Norway Poland Slovakia Slovenia Spain Sweden
United Kingdom
Contacts
Name: Pawel Waszka   
Address:  1030 Sync Street 27560 Morrisville, North Carolina United States
Telephone: +48222564220
Email: pawel.waszka@syneoshealth.com
Affiliation:  Syneos Health
Name: Pawel Waszka   
Address:  1030 Sync Street 27560 Morrisville, North Carolina United States
Telephone: +48222564220
Email: pawel.waszka@syneoshealth.com
Affiliation:  Syneos Health
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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
Intervention(s)

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

Primary Outcome(s)
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).
Timepoint(s) of evaluation of this end point: week 12
Primary end point(s): Absolute change in ALP from baseline to Week 12 in the DB Treatment Period
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
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Baseline to End of study
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
Secondary ID(s)
2018-002575-17-HU
747-213
Source(s) of Monetary Support
Intercept Pharmaceuticals, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 19/09/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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