Clinical trial NCT01378104: 100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
Official 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%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sustained Virologic Response
IL28B Polymorphism
Keywords: reducing dose of peginterferon
chronic hepatitis c
Koreans
IL28B polymorphism
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
name: National Health Insurance Service Ilsan Hospital
name: Inje University
name: Soonchunhyang University Hospital
name: Yonsei University
name: Chungnam National University
name: Keimyung University
name: Kyungpook National University Hospital
name: Konyang University Hospital
name: Inha University Hospital
name: Hallym University Medical Center
First posted: 2011-06-22
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
timeFrame: post treatment 24 weeks
Secondary outcomes:
measure: IL28B Polymorphism Effect on SVR
timeFrame: post treatment 24 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunghyang University Hospital
city: Chunchun
country: Korea, Republic of
facility: Hallym University Chunchun Medical center
city: Daegu
country: Korea, Republic of
facility: Keimyung University hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejun
country: Korea, Republic of
facility: Ghungnam National University hospital
city: Daejun
country: Korea, Republic of
facility: Konyang University hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University hospital
city: Koyang-si
country: Korea, Republic of
facility: Inje University, Ilsan Paik Hospital
city: Koyang-si
country: Korea, Republic of
facility: NHIC Ilsan hospital
city: Pusan
country: Korea, Republic of
facility: Inje University, Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Ulsan
country: Korea, Republic of
facility: Ulsan university
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University, Wonju Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jung Hyun Kwon, MD, Assistant professor
role: PRINCIPAL_INVESTIGATOR
References: