Clinical trial NCT00249860: A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
Official title: A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Subjects with chronic hepatitis C who have never previously received interferon therapy.
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck Pte. Ltd., Singapore
First posted: 2005-11-07
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of subjects achieving sustained viral response (SVR) at Week 24
timeFrame: Week 24
measure: Percentage of subjects achieving sustained viral response (SVR) at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
timeFrame: Baseline, Week 12, 24, and 48
measure: Percentage of subjects with Alanine transaminase (ALT) normalization
timeFrame: Week 12, 24, and 48
measure: Percentage of subjects with viral clearance
timeFrame: Week 12 and 24
measure: Percentage of subjects with both SVR and sustained ALT normalization
timeFrame: Week 48
measure: Number of subjects with improvement in the liver necroinflammation score by at least two points
timeFrame: Week 48
measure: Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
timeFrame: Week 48
measure: Number of subjects with adverse events and serious adverse events
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
name: Theodor Wee, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.