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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Korean CHC

Arm Description

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.

Outcomes

Primary Outcome Measures

The proportion of patients achieving sustained virological response (SVR)
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)
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)
cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
The proportion of patients achieving end-of-treatment response (ETR)
ETR is defined as HCV RNA undetectable at the end of treatment.

Full Information

First Posted
May 7, 2012
Last Updated
May 12, 2012
Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01596517
Brief Title
Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
Official Title
Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Korean CHC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
Primary Outcome Measure Information:
Title
The proportion of patients achieving sustained virological response (SVR)
Description
SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment
Time Frame
at 24 weeks after cessation of treatment
Secondary Outcome Measure Information:
Title
The proportion of patients achieving early virological response (EVR)
Description
EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment
Time Frame
at 12 weeks of treatment
Title
the proportion of patients achieving complete EVR (cEVR)
Description
cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
Time Frame
at 12 weeks of treatment
Title
The proportion of patients achieving end-of-treatment response (ETR)
Description
ETR is defined as HCV RNA undetectable at the end of treatment.
Time Frame
at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Suk Lim, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23593611
Citation
Heo NY, Lim YS, Lee HC, Lee YS, Kim KM, Byun KS, Han KH, Lee KS, Paik SW, Yoon SK, Suh DJ. High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice. Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25.
Results Reference
derived

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

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