Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
NCT03092765 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2019-01-04
Summary
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
Conditions
Interventions
- DRUG
-
E6011
Intravenous administration
- DRUG
-
Intravenous administration
Sponsors & Collaborators
-
EA Pharma Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-29
- Primary Completion
- 2018-08-27
- Completion
- 2018-10-22
Countries
- Japan
Study Locations
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