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NCT00668070 Clinical Trial

A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

Non-Alcoholic Steatohepatitis Clinical Trial

— ASTER  

Official title:
Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00668070
Other study ID # 9831-CL-0301
Secondary ID 2007-002114-19
Status Completed
Phase Phase 2
First received April 24, 2008
Last updated March 19, 2013
Start date April 2008
Est. completion date October 2010

Study information
Verified date November 2010
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Czech Republic: State Institute for Drug ControlBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentRomania: National Medicines AgencySwitzerland: Swissmedic
Study type Interventional

Clinical Trial 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

Description:

The study includes an open-label sub-study prior to the main study

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization

- Elevated serum ALT levels

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ASP9831
Oral
• Placebo
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Romania,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary ALT 12 Weeks No
See also
  Status Clinical Trial Phase
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Recruiting NCT05065593 - The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis N/A
Terminated NCT04171765 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis Phase 2
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Active, not recruiting NCT02912260 - Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT06054815 - Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH Phase 2
Completed NCT02784444 - A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH Phase 2
Not yet recruiting NCT06160271 - Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis Phase 2
Active, not recruiting NCT05573204 - Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients With Non-alcoholic Steatohepatitis Phase 2
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Completed NCT04657523 - Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study N/A
Completed NCT04142424 - A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects Phase 1
Terminated NCT02787304 - Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT04666402 - Integrated Diagnostics for Early Diagnosis of Liver Disease
Completed NCT02528305 - The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis N/A
Recruiting NCT01056133 - Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT02960204 - Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension Phase 2
Completed NCT04806750 - Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension Phase 2
Recruiting NCT05751720 - Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue Phase 1/Phase 2

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