Efficacy and Safety of MT-3995 in Patients With Non-Alcoh... | NCT02923154

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

NCT02923154

Sponsor

Tanabe Pharma Corporation

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

48Actual

Phase

Phase 2

Conditions

NASH

Interventions

MT-3995
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Mar 2018Actual

Completion Date

Apr 2019Actual

First Submitted Date

Oct 2, 2016

First Submission Date that Met QC Criteria

Oct 2, 2016

First Posted Date

Oct 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2019

Last Update Posted Date

Sep 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Label	Type	Description	Intervention Names
MT-3995	Experimental		Drug: MT-3995
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MT-3995	Drug		MT-3995
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline in ALT		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in ALT		24 weeks
Adverse events		From baseline to 72 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
General Manager	Tanabe Pharma Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site		Kanagawa			Japan
Investigational site

Intervention Browse Module

MeSH Terms

ID	Term
C000719999	apararenone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided