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

NCT00249860 | Completed Phase 3

• 1 other identifier: 23744
• Study Type: interventional
• Target: 257
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatitis C

Keywords

Subjects with chronic hepatitis C who have never previously received interferon therapy.

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects achieving sustained viral response (SVR) at Week 24

  Week 24

• Percentage of subjects achieving sustained viral response (SVR) at Week 48

  Week 48

Secondary Outcomes (7)

• Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48

  Baseline, Week 12, 24, and 48

• Percentage of subjects with Alanine transaminase (ALT) normalization

  Week 12, 24, and 48

• Percentage of subjects with viral clearance

  Week 12 and 24

• Percentage of subjects with both SVR and sustained ALT normalization

  Week 48

• Number of subjects with improvement in the liver necroinflammation score by at least two points

  Week 48

Study Arms (2)

Interferon-beta-1a

EXPERIMENTAL

Drug: Interferon-beta-1a

Ribavarin plus interferon-beta-1a

ACTIVE COMPARATOR

Drug: Placebo; Drug: Ribavirin plus Interferon-beta-1a

Interventions

Interferon-beta-1a DRUG

Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24

Interferon-beta-1a

Placebo DRUG

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

Ribavarin plus interferon-beta-1a

Ribavirin plus Interferon-beta-1a DRUG

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

Ribavarin plus interferon-beta-1a

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EMD Serono: lead
• Merck Pte. Ltd., Singapore: collaborator

Related Publications (1)

• Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.

  PMID: 17654600 RESULT

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Hepatitis C

Interventions

Interferon beta-1a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Theodor Wee, M.D.

  Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 7, 2005
• Study Start: September 1, 2002
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: August 6, 2013

Record last verified: 2013-08