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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 3

Conditions

Hepatitis C

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Enrollment

257 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

257 participants in 2 patient groups

Interferon-beta-1a
Experimental group
Treatment:
Drug: Interferon-beta-1a
Ribavarin plus interferon-beta-1a
Active Comparator group
Treatment:
Drug: Ribavirin plus Interferon-beta-1a
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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