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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroyuki Marusawa, Kyoto University
ClinicalTrials.gov Identifier:
NCT00216775
First received: September 10, 2005
Last updated: September 1, 2015
Last verified: September 2015
  Purpose
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)
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with chronic hepatitis C
Criteria

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 ClinicalTrials.gov identifier: NCT00216775

Locations
Japan
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
Investigators
Study Chair: Tsutomu Chiba, M.D., Ph.D Kyoto University
  More Information

Responsible Party: Hiroyuki Marusawa, Dep Gastroenterol, Kyoto University
ClinicalTrials.gov 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
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016