PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
NCT ID: NCT01056172
Last Updated: 2012-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
164 participants
INTERVENTIONAL
2010-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A. 24 weeks in RVR patients.
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.
Peginterferon alfa-2a and Ribavirin
1. PegIFN alfa-2a (PEgasys) 180 ug/week
2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day)
3. Treatment duration: 24 weeks
B. 16 weeks in RVR patients.
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.
Peginterferon alfa-2a and Ribavirin
1. PegIFN alfa-2a (PEgasys) 180 ug/week
2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day)
3. Treatment duration: 16 weeks
Interventions
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Peginterferon alfa-2a and Ribavirin
1. PegIFN alfa-2a (PEgasys) 180 ug/week
2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day)
3. Treatment duration: 16 weeks
Peginterferon alfa-2a and Ribavirin
1. PegIFN alfa-2a (PEgasys) 180 ug/week
2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day)
3. Treatment duration: 24 weeks
Eligibility Criteria
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Inclusion Criteria
2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
3. Detectable serum quantitative HCV-RNA
4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
5. Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Exclusion Criteria
2. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
3. Decompensated liver disease (Child-Pugh class B or C)
4. Neoplastic disease within 5 years
5. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
6. Women with ongoing pregnancy or breast feeding
7. Hgb \< 11 g/dL in women or \< 12 g/dL in men at screening
8. Neutrophil count \< 1500 cells/mm3 or platelet count \< 90,000 cells/mm3 at screening
9. Serum creatinine level \> 1.5 times the upper limit of normal at screening
10. Serum alpha-fetoprotein \> 100 ng/mL
11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
12. History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
13. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
14. History of a severe seizure disorder or current anticonvulsant use
15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
16. Inability or unwillingness to provide informed consent or abide by the requirements of the study
18 Years
ALL
No
Sponsors
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Severance Hospital
OTHER
Pusan National University Hospital
OTHER
Incheon St.Mary's Hospital
OTHER
Soon Chun Hyang University
OTHER
Inje University
OTHER
Inje University Ilsan Paik Hospital
OTHER
Inje University Haeundae Paik Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Ki Tae Yoon
Assistant Professor
Principal Investigators
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Ki Tae Yoon, M.D
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, , South Korea
Pusan National University Hospital
Busan, , South Korea
Inje University Pusan Paik Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
Incheon St. Mary's Hospital
Incheon, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PNUYH-CHC001
Identifier Type: -
Identifier Source: org_study_id
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