NCT01596517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

8.5 years

First QC Date

May 7, 2012

Last Update Submit

May 12, 2012

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • The proportion of patients achieving early virological response (EVR)

    at 12 weeks of treatment

  • the proportion of patients achieving complete EVR (cEVR)

    at 12 weeks of treatment

  • The proportion of patients achieving end-of-treatment response (ETR)

    at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3

Study Arms (1)

Korean CHC

EXPERIMENTAL

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 1Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3

Interventions

Peginterferon alfa-2a plus ribavirin for HCV genotype 1DRUG

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.

Also known as: Pegasys, Copegus
Korean CHC
Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3DRUG

Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.

Also known as: Pegasys, Copegus
Korean CHC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23593611DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Young-Suk Lim, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 11, 2012

Study Start

June 1, 2003

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

KR(1)