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

This study has been completed.
Sponsor:
Collaborator:
Merck Pte. Ltd., Singapore
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00249860
First received: November 4, 2005
Last updated: August 4, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Interferon-beta-1a
Drug: Placebo
Drug: Ribavirin plus Interferon-beta-1a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percentage of subjects achieving sustained viral response (SVR) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving sustained viral response (SVR) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of subjects with Alanine transaminase (ALT) normalization [ Time Frame: Week 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Percentage of subjects with viral clearance [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with both SVR and sustained ALT normalization [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of subjects with improvement in the liver necroinflammation score by at least two points [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events and serious adverse events [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: Yes ]

Enrollment: 257
Study Start Date: September 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249860

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

Additional Information:
Publications:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00249860     History of Changes
Other Study ID Numbers: 23744
Study First Received: November 4, 2005
Last Updated: August 4, 2013
Health Authority: Hong Kong: Department of Health

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

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

ClinicalTrials.gov processed this record on April 14, 2014