100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
- Conditions
- Sustained Virologic ResponseIL28B Polymorphism
- Interventions
- Drug: peginterferon alfa 2a (pegasys)Drug: peginterferon alfa-2a (pegasys)
- Registration Number
- NCT01378104
- Lead Sponsor
- The Catholic University of Korea
- Brief Summary
1. Randomized controlled multicenter study
2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
3. IL28B polymorphism in Koreans with CHC
- Detailed Description
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- chronic hepatitis C (anti HCV+, HCV RNA +)
- Genotype 1
- over 18 year-old
- Pregnancy test negative if women of childbearing age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 80% dosage group of peginterferon alfa 2a peginterferon alfa 2a (pegasys) This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. 100% dosage group of peginterferon alfa 2a peginterferon alfa-2a (pegasys) These group patients would be treated with standard dose 180 ug/week for 48 weeks.
- Primary Outcome Measures
Name Time Method Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a post treatment 24 weeks We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
- Secondary Outcome Measures
Name Time Method IL28B Polymorphism Effect on SVR post treatment 24 weeks We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.
Trial Locations
- Locations (14)
Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Ghungnam National University hospital
🇰🇷Daejun, Korea, Republic of
Inha University hospital
🇰🇷Incheon, Korea, Republic of
Inje University, Ilsan Paik Hospital
🇰🇷Koyang-si, Korea, Republic of
Yonsei University, Wonju Hospital
🇰🇷Wonju-si, Korea, Republic of
Ulsan university
🇰🇷Ulsan, Korea, Republic of
Soonchunghyang University Hospital
🇰🇷Bucheon, Korea, Republic of
Keimyung University hospital
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Hallym University Chunchun Medical center
🇰🇷Chunchun, Korea, Republic of
Konyang University hospital
🇰🇷Daejun, Korea, Republic of
NHIC Ilsan hospital
🇰🇷Koyang-si, Korea, Republic of
Inje University, Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of