Hepatitis C
Conditions
Keywords
Subjects with chronic hepatitis C who have never previously received interferon therapy.
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).
Interventions
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
DRUGPlacebo
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
DRUGRibavirin 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
Sponsors
Merck Pte. Ltd., Singapore
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Percentage of subjects with viral clearance | Week 12 and 24 |
| Percentage of subjects with both SVR and sustained ALT normalization | Week 48 |
| 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 |
| Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point | Week 48 |
| Number of subjects with adverse events and serious adverse events | Baseline up to Week 48 |
| Number of subjects with improvement in the liver necroinflammation score by at least two points | Week 48 |
| Percentage of subjects with Alanine transaminase (ALT) normalization | Week 12, 24, and 48 |
Outcome results
None listed