- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923154
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
September 4, 2019 updated by: Mitsubishi Tanabe Pharma Corporation
An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kanagawa, Japan
- Investigational Site
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Osaka, Japan
- Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects diagnosed with NASH before randomization
- Subjects who conducts diet or exercise therapy at the beginning of run in period.
- Subjects who has given full and adequate information of the protocol and with written informed consent
Exclusion Criteria:
- Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
- Subjects with alcohol dependence or previously diagnosed with alcohol dependence
- Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
- Presence, history, or family history of long QT syndrome or Torsades de Pointes
- Subjects with heart failure (New York Heart Association Class III-IV)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: MT-3995
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change from baseline in ALT
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in ALT
Time Frame: 24 weeks
|
24 weeks
|
Adverse events
Time Frame: From baseline to 72 weeks
|
From baseline to 72 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
October 2, 2016
First Submitted That Met QC Criteria
October 2, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Actual)
September 6, 2019
Last Update Submitted That Met QC Criteria
September 4, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-3995-J07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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