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Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Collaborators:
Samsung Medical Center
Severance Hospital
Gangnam Severance Hospital
Seoul St. Mary's Hospital
Korea University Guro Hospital
Information provided by (Responsible Party):
Young-Suk Lim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01596517
First received: May 7, 2012
Last updated: May 12, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • The proportion of patients achieving sustained virological response (SVR) [ Time Frame: at 24 weeks after cessation of treatment ] [ Designated as safety issue: No ]
    SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment


Secondary Outcome Measures:
  • The proportion of patients achieving early virological response (EVR) [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
    EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment

  • the proportion of patients achieving complete EVR (cEVR) [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
    cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment

  • The proportion of patients achieving end-of-treatment response (ETR) [ Time Frame: at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3 ] [ Designated as safety issue: No ]
    ETR is defined as HCV RNA undetectable at the end of treatment.


Enrollment: 272
Study Start Date: June 2003
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Korean CHC
Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008.
 Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.
Other Names:
  • Pegasys
  • Copegus
Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
Other Names:
  • Pegasys
  • Copegus

Detailed Description:

A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: all of below

  • adults aged 18-70 years
  • serum anti-HCV antibody (+)
  • HCV RNA detectable by PCR
  • compensated liver disease (Child-Pugh class A)

Exclusion Criteria: any of below

  • HCV genotype other than 1, 2, or 3
  • acute hepatitis C
  • decompensated cirrhosis or hepatocellular carcinoma
  • other liver disease such as hepatitis A or B, or autoimmune hepatitis
  • HIV Ab(+)
  • severe depression or other psychiatric disease
  • previous organ transplantation
  • absolute neutrophil count (ANC) < 1,000 cells/mm3 or platelet count < 75,000 cells/mm3, or hemoglobin (Hb) < 13 g/dL for men, <12 g/dL for women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596517

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Samsung Medical Center
Severance Hospital
Gangnam Severance Hospital
Seoul St. Mary's Hospital
Korea University Guro Hospital
Investigators
Principal Investigator: Young-Suk Lim, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Young-Suk Lim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01596517     History of Changes
Other Study ID Numbers: AMC2003-0059
Study First Received: May 7, 2012
Last Updated: May 12, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013