100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01378104
• Date of registration: 16/06/2011
• Primary sponsor: The Catholic University of Korea
• Public title: 100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
• Scientific title: The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
• Date of first enrolment: October 2008
• Target sample size: 178
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01378104
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jung Hyun Kwon, MD, Assiatant professor

• Name: Jung Hyun Kwon, MD, Assistant professor
• Affiliation: The Catholic University of Korea

Key inclusion & exclusion criteria

Inclusion Criteria:

- chronic hepatitis C (anti HCV+, HCV RNA +)

- Genotype 1

- over 18 year-old

- Pregnancy test negative if women of childbearing age

Exclusion Criteria:

- pregnant women or breast feeding women

- systemic chemotherapy or steroid therapy before 6 months of trial

- Coinfection with HAV, HBV, and HIV

- Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver
disease, alcoholic liver disease, toxic hepatitis

- Hepatocellular carcinoma

- Evidence of decompensation such as variceal bleeding,ascites, encephalopathy

- ANC less than 1500, platelet less than 90k

- Cr more than 1.5 of UNL

- Severe psychiatric problem

- Poorly controlled thyroid disease

- Severe retinopathy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

IL28B Polymorphism

Sustained Virologic Response

Intervention(s)

Drug: peginterferon alfa 2a (pegasys)

Drug: peginterferon alfa-2a (pegasys)

Primary Outcome(s)

Sustained virologic response depending on the dosage of peginterferon alfa 2a [Time Frame: post treatment 24 weeks]

Secondary Outcome(s)

IL28B polymorphism effect on SVR [Time Frame: post treatment 24 weeks]

Secondary ID(s)

PEGASYS100:80

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chungnam National University

Hallym University Medical Center

Inha University Hospital

Inje University

Keimyung University

Konyang University Hospital

Kyungpook National University

NHIC Ilsan hospital

Soonchunhyang University Hospital

Ulsan University Hospital

Yonsei University