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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249860
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : August 6, 2013
Merck Pte. Ltd., Singapore
Information provided by (Responsible Party):
EMD Serono

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Interferon-beta-1a Drug: Placebo Drug: Ribavirin plus Interferon-beta-1a Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
Study Start Date : September 2002
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Percentage of subjects achieving sustained viral response (SVR) at Week 24 [ Time Frame: Week 24 ]
  2. Percentage of subjects achieving sustained viral response (SVR) at Week 48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of subjects with Alanine transaminase (ALT) normalization [ Time Frame: Week 12, 24, and 48 ]
  3. Percentage of subjects with viral clearance [ Time Frame: Week 12 and 24 ]
  4. Percentage of subjects with both SVR and sustained ALT normalization [ Time Frame: Week 48 ]
  5. Number of subjects with improvement in the liver necroinflammation score by at least two points [ Time Frame: Week 48 ]
  6. Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point [ Time Frame: Week 48 ]
  7. Number of subjects with adverse events and serious adverse events [ Time Frame: Baseline up to Week 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249860

Sponsors and Collaborators
EMD Serono
Merck Pte. Ltd., Singapore
Study Director: Theodor Wee, M.D. Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore

Additional Information:
Publications of Results:
Responsible Party: EMD Serono Identifier: NCT00249860     History of Changes
Other Study ID Numbers: 23744
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: August 2013

Keywords provided by EMD Serono:
Subjects with chronic hepatitis C who have never previously received interferon therapy.

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic