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

Chronic Hepatitis C Clinical Trial

Official title:

Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596517
• Other study ID #: AMC2003-0059
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: May 12, 2012
• Start date: June 2003
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Patients with genotype 1: treatment with peginterferon a-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.
• Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Patients with genotype 2 or 3: treatment with peginterferon a-2a 180 µg/week and daily ribavirin dose of 800 mg for 24 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Asan Medical Center	Gangnam Severance Hospital, Korea University Guro Hospital, Samsung Medical Center, Seoul St. Mary's Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 24 weeks after cessation of treatment	No
Secondary	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	at 12 weeks of treatment	No
Secondary	the proportion of patients achieving complete EVR (cEVR)	cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment	at 12 weeks of treatment	No
Secondary	The proportion of patients achieving end-of-treatment response (ETR)	ETR is defined as HCV RNA undetectable at the end of treatment.	at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3	No