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Trial record 1 of 1 for:    MT-3995-J07
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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

Tracking Information
First Submitted Date  ICMJE October 2, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2016)
Percent change from baseline in ALT [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02923154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2016)
  • Change from baseline in ALT [ Time Frame: 24 weeks ]
  • Adverse events [ Time Frame: From baseline to 72 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
Official Title  ICMJE An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE NASH
Intervention  ICMJE
  • Drug: MT-3995
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: MT-3995
    Intervention: Drug: MT-3995
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923154
Other Study ID Numbers  ICMJE MT-3995-J07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP