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
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, see Learn About Clinical Studies.

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 1a
Interferon-beta
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 15, 2014