NCT00668070

Brief Summary

The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Geographic Reach
7 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 21, 2013

Status Verified

November 1, 2010

Enrollment Period

2.5 years

First QC Date

April 24, 2008

Last Update Submit

March 19, 2013

Conditions

Non-Alcoholic Steatohepatitis

Keywords

NASHChronic liver disease

Outcome Measures

Primary Outcomes (1)

  • ALT

    12 Weeks

Study Arms (3)

ASP9831 Low Dose

EXPERIMENTAL
Drug: ASP9831

ASP9831 Higher Dose

EXPERIMENTAL
Drug: ASP9831

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ASP9831DRUG

Oral

ASP9831 Higher DoseASP9831 Low Dose
PlaceboDRUG

Oral

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
  • Elevated serum ALT levels

You may not qualify if:

  • Hepatic cirrhosis
  • Other known cause of liver disease
  • Uncontrolled diabetes mellitis type 2, i.e. HbA1c \> 8.5%
  • Positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination
  • History of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males
  • Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Antwerp, 2650, Belgium

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

La Louvière, 7100, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Brno-Bohunice, 62500, Czechia

Location

Unknown Facility

Prague, 14021, Czechia

Location

Unknown Facility

Prague, 18000, Czechia

Location

Unknown Facility

Amiens, France

Location

Unknown Facility

Angers, 49933, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Paris, 75571, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Pessac, 33604, France

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Frankfurt am Main, 60590, Germany

Location

Unknown Facility

Mainz, 55101, Germany

Location

Unknown Facility

Regensburg, 93042, Germany

Location

Unknown Facility

Bucharest, 021105, Romania

Location

Unknown Facility

Bucharest, 022328, Romania

Location

Unknown Facility

Iași, 700111, Romania

Location

Unknown Facility

Timișoara, 300736, Romania

Location

Unknown Facility

Basel, 4031, Switzerland

Location

Unknown Facility

Bern, 3010, Switzerland

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, NE77DN, United Kingdom

Location

Unknown Facility

Nottingham, NG77DN, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Use central contact

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 21, 2013

Record last verified: 2010-11

Locations

RO(4)GB(4)FR(6)DE(5)BE(5)CH(3)CZ(3)