100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
NCT ID: NCT01378104
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
178 participants
INTERVENTIONAL
2008-10-31
2012-09-30
Brief Summary
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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
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Detailed Description
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-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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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80% dosage group of peginterferon alfa 2a
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.
peginterferon alfa 2a (pegasys)
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
100% dosage group of peginterferon alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
peginterferon alfa-2a (pegasys)
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
Interventions
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peginterferon alfa 2a (pegasys)
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
peginterferon alfa-2a (pegasys)
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Genotype 1
* over 18 year-old
* Pregnancy test negative if women of childbearing age
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ulsan University Hospital
OTHER
National Health Insurance Service Ilsan Hospital
OTHER
Inje University
OTHER
Soonchunhyang University Hospital
OTHER
Yonsei University
OTHER
Chungnam National University
OTHER
Keimyung University
OTHER
Kyungpook National University Hospital
OTHER
Konyang University Hospital
OTHER
Inha University Hospital
OTHER
Hallym University Medical Center
OTHER
The Catholic University of Korea
OTHER
Responsible Party
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Jung Hyun Kwon
Assistant professor
Principal Investigators
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Jung Hyun Kwon, MD, Assistant professor
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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Soonchunghyang University Hospital
Bucheon-si, , South Korea
Hallym University Chunchun Medical center
Chunchun, , South Korea
Keimyung University hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Ghungnam National University hospital
Daejun, , South Korea
Konyang University hospital
Daejun, , South Korea
Incheon St. Mary's Hospital
Incheon, , South Korea
Inha University hospital
Incheon, , South Korea
Inje University, Ilsan Paik Hospital
Koyang-si, , South Korea
NHIC Ilsan hospital
Koyang-si, , South Korea
Inje University, Pusan Paik Hospital
Pusan, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Ulsan university
Ulsan, , South Korea
Yonsei University, Wonju Hospital
Wŏnju, , South Korea
Countries
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Other Identifiers
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PEGASYS100:80
Identifier Type: -
Identifier Source: org_study_id
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