A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

August 4, 2013 updated by: EMD Serono

A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.

This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.

The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
  • Had adequate bone marrow reserve and organ function
  • Are not pregnant and are willing to use contraception, if, of childbearing potential
  • Are willing and able to comply with the protocol and to give written informed consent
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
  • History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
  • Any cause for the liver disease other than chronic hepatitis C
  • Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
  • Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
  • Previous systemic treatment for Hepatitis C with an interferon or ribavirin
  • Presence of systemic disease that might interfere with subject safety, compliance or evaluation
  • Known allergies to acetaminophen, human serum albumin or mannitol;
  • Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
  • Bearing organ transplants (except cornea)
  • Other protocol defined exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interferon-beta-1a
Drug: Interferon-beta-1a
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
Active Comparator: Ribavarin plus interferon-beta-1a
Drug: Placebo
Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Drug: Ribavirin plus Interferon-beta-1a
Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving sustained viral response (SVR) at Week 24
Time Frame: Week 24
Week 24
Percentage of subjects achieving sustained viral response (SVR) at Week 48
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
Time Frame: Baseline, Week 12, 24, and 48
Baseline, Week 12, 24, and 48
Percentage of subjects with Alanine transaminase (ALT) normalization
Time Frame: Week 12, 24, and 48
Week 12, 24, and 48
Percentage of subjects with viral clearance
Time Frame: Week 12 and 24
Week 12 and 24
Percentage of subjects with both SVR and sustained ALT normalization
Time Frame: Week 48
Week 48
Number of subjects with improvement in the liver necroinflammation score by at least two points
Time Frame: Week 48
Week 48
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
Time Frame: Week 48
Week 48
Number of subjects with adverse events and serious adverse events
Time Frame: Baseline up to Week 48
Baseline up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Merck Pte. Ltd., Singapore

Investigators

  • Study Director: Theodor Wee, M.D., Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23744

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Interferon-beta-1a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe