This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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 Hiroyuki Marusawa, Kyoto University:

Primary Outcome Measures:
  • rate of sustained viral response [ Time Frame: 6 months ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017