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PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

Information source: Pusan National University Yangsan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Peginterferon alfa-2a and Ribavirin (Drug); Peginterferon alfa-2a and Ribavirin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pusan National University Yangsan Hospital

Official(s) and/or principal investigator(s):
Ki Tae Yoon, M.D, Principal Investigator, Affiliation: Pusan National University Yangsan Hospital

Overall contact:
Ki Tae Yoon, M.D, Phone: +82-55-360-2362, Email: ktyoon@pusan.ac.kr

Summary

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Clinical Details

Official title: A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained virologic response (SVR)

Secondary outcome:

AEs

laboratory parameters

vital signs

Detailed description: In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age older than 18 years old 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: 1. Co-infection with hepatitis B and/or human immunodeficiency virus (HIV) 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

Locations and Contacts

Ki Tae Yoon, M.D, Phone: +82-55-360-2362, Email: ktyoon@pusan.ac.kr

Soon Chun Hyang University Bucheon Hospital, Bucheon 420-767, Korea, Republic of; Recruiting
Young Seok Kim, Phone: 82-10-6360-2635, Email: liverkys@schbc.ac.kr
Young Seok Kim, Principal Investigator

Inje University Haeundae Paik Hospital, Busan, Korea, Republic of; Recruiting
Seung Ha Park, M.D., Phone: +82-10-4718-4545, Email: obgyy@medimail.co.kr
Seung Ha Park, M.D., Principal Investigator

Inje University Pusan Paik Hospital, Busan 633-165, Korea, Republic of; Recruiting
Youn Jae Lee, Phone: 08-10-7747-9281, Email: yjyh0105@inje.ac.kr
Eun Uk Jung, Sub-Investigator
Youn Jae Lee, Principal Investigator

Pusan National University Hospital, Busan 602-739, Korea, Republic of; Recruiting
Jeong Heo, M.D, Ph.D, Phone: +82-51-240-7869, Email: jheo@pusan.ac.kr
Jeong Heo, M.D, Ph.D, Principal Investigator
Hyun Young Woo, Sub-Investigator

Inje University Ilsan Paik Hospital, Goyang, Korea, Republic of; Active, not recruiting

Incheon St. Mary's Hospital, Incheon, Korea, Republic of; Recruiting
Jeong Won Jang, Phone: 82-11-204-9400, Email: garden@catholic.ac.kr
Jeong Woon Jang, Principal Investigator
Jung Hyun Kwon, Sub-Investigator

Severance Hospital, Seoul 120-752, Korea, Republic of; Recruiting
Jun Yong Park, M.D, Phone: +82-10-8353-0670, Email: drpjy@yuhs.ac
Jun Yong Park, M.D, Principal Investigator

Pusan National University Yangsan Hospital, Yangsan, Gyeongnam 626-770, Korea, Republic of; Recruiting
Ki Tae Yoon, M.D, Phone: +82-55-360-2362, Email: ktyoon@pusan.ac.kr
Ki Tae Yoon, M.D, Principal Investigator
Mong Cho, Sub-Investigator

Additional Information

Starting date: January 2010
Last updated: April 18, 2012

Page last updated: August 23, 2015

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