|
Main
|
|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 July 2022 |
|
Main ID: |
NCT03226067 |
|
Date of registration:
|
30/06/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
|
|
Scientific title:
|
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase |
|
Date of first enrolment:
|
June 26, 2017 |
|
Target sample size:
|
111 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03226067 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
|
Germany
|
Greece
|
Israel
|
Italy
|
Spain
|
United Kingdom
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Philippe Wiesel, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Calliditas Therapeutics AB |
| | |
|
Key inclusion & exclusion criteria
|
|
Health Condition(s) or Problem(s) studied
|
|
Source(s) of Monetary Support
|
|