Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C

This study has been completed.
Information provided by (Responsible Party):
Hiroyuki Marusawa, Kyoto University Identifier:
First received: September 10, 2005
Last updated: September 1, 2015
Last verified: September 2015

The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: interferon-alfa-2b and ribavirin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • rate of sustained viral response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: December 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with chronic hepatitis C


Inclusion Criteria:

  • Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses

Exclusion Criteria:

  • Hemoglobin levels<8.5g/dL,
  • Platelet counts<50,000/mm3,
  • Total polymorphonuclear counts<1000/mm3
  • Pregnancy,
  • Renal dysfunction,
  Contacts and Locations
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Please refer to this study by its identifier: NCT00216775

Department of Gastroenterology and Hepatology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Kitano Hospital
Osaka, Japan
Osaka Red Cross Hospital
Osaka, Japan
Wakayama Red Cross Hospital
Wakayama, Japan
Sponsors and Collaborators
Kyoto University
Study Chair: Tsutomu Chiba, M.D., Ph.D Kyoto University
  More Information

No publications provided

Responsible Party: Hiroyuki Marusawa, Dep Gastroenterol, Kyoto University Identifier: NCT00216775     History of Changes
Other Study ID Numbers: H16-697
Study First Received: September 10, 2005
Last Updated: September 1, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 09, 2015