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
  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:


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
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: 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 by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014