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Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)

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ClinicalTrials.gov Identifier: NCT02923154
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NASH Drug: MT-3995 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
Study Start Date : September 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: MT-3995 Drug: MT-3995
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Percent change from baseline in ALT [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in ALT [ Time Frame: 24 weeks ]
  2. Adverse events [ Time Frame: From baseline to 72 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923154


Locations
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Japan
Investigational site
Kanagawa, Japan
Investigational site
Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02923154     History of Changes
Other Study ID Numbers: MT-3995-J07
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
NASH

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases