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

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ClinicalTrials.gov Identifier: NCT00216775
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Hiroyuki Marusawa, Kyoto University

Brief Summary:
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 or disease Intervention/treatment
Hepatitis C, Chronic Drug: interferon-alfa-2b and ribavirin

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hiroyuki Marusawa, Dep Gastroenterol, Kyoto University
ClinicalTrials.gov Identifier: NCT00216775     History of Changes
Other Study ID Numbers: H16-697
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus 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