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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249860
• Other study ID #: 23744
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2005
• Last updated: August 4, 2013
• Start date: September 2002
• Est. completion date: August 2005

Study information

• Verified date: August 2013
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	Merck Pte. Ltd., Singapore

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving sustained viral response (SVR) at Week 24		Week 24	No
Primary	Percentage of subjects achieving sustained viral response (SVR) at Week 48		Week 48	No
Secondary	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	No
Secondary	Percentage of subjects with Alanine transaminase (ALT) normalization		Week 12, 24, and 48	No
Secondary	Percentage of subjects with viral clearance		Week 12 and 24	No
Secondary	Percentage of subjects with both SVR and sustained ALT normalization		Week 48	No
Secondary	Number of subjects with improvement in the liver necroinflammation score by at least two points		Week 48	No
Secondary	Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point		Week 48	No
Secondary	Number of subjects with adverse events and serious adverse events		Baseline up to Week 48	Yes

External Links

•   Full FDA approved prescribing information can be found here