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Completed

NCT Number: NCT01596517

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a plus ribavirin for HCV genotype 1

Drug

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

Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3

Drug

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

Primary outcomes

  1. The proportion of patients achieving sustained virological response (SVR)

    Time frame: at 24 weeks after cessation of treatment

    SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment

Secondary outcomes

  1. The proportion of patients achieving early virological response (EVR)

    Time frame: at 12 weeks of treatment

    EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment

  2. the proportion of patients achieving complete EVR (cEVR)

    Time frame: at 12 weeks of treatment

    cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment

  3. 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

    ETR is defined as HCV RNA undetectable at the end of treatment.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Gangnam Severance Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul St. Mary's Hospital
  • Severance Hospital

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2012
First posted
May 11, 2012
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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