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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: Peginterferon alfa-2a and Ribavirin; Drug: Peginterferon alfa-2a and Ribavirin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of, 420-767
    • Recruiting
    • Soon Chun Hyang University Bucheon Hospital
    • Contact: Young Seok Kim; Phone Number: 82-10-6360-2635; Email: liverkys@schbc.ac.kr
    • Principal Investigator: Young Seok Kim
  • Busan, Korea, Republic of, 602-739
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jeong Heo, M.D, Ph.D; Phone Number: +82-51-240-7869; Email: jheo@pusan.ac.kr
    • Principal Investigator: Jeong Heo, M.D, Ph.D
    • Sub-Investigator: Hyun Young Woo
  • Busan, Korea, Republic of
    • Recruiting
    • Inje University Haeundae Paik Hospital
    • Contact: Seung Ha Park, M.D.; Phone Number: +82-10-4718-4545; Email: obgyy@medimail.co.kr
    • Principal Investigator: Seung Ha Park, M.D.
  • Busan, Korea, Republic of, 633-165
    • Recruiting
    • Inje University Pusan Paik Hospital
    • Contact: Youn Jae Lee; Phone Number: 08-10-7747-9281; Email: yjyh0105@inje.ac.kr
    • Sub-Investigator: Eun Uk Jung
    • Principal Investigator: Youn Jae Lee
  • Goyang, Korea, Republic of
    • Active, not recruiting
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Recruiting
    • Incheon St. Mary's Hospital
    • Contact: Jeong Won Jang; Phone Number: 82-11-204-9400; Email: garden@catholic.ac.kr
    • Principal Investigator: Jeong Woon Jang
    • Sub-Investigator: Jung Hyun Kwon
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Jun Yong Park, M.D; Phone Number: +82-10-8353-0670; Email: drpjy@yuhs.ac
    • Principal Investigator: Jun Yong Park, M.D
  • Gyeongnam
    • Yangsan, Gyeongnam, Korea, Republic of, 626-770
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Ki Tae Yoon, M.D; Phone Number: +82-55-360-2362; Email: ktyoon@pusan.ac.kr
      • Principal Investigator: Ki Tae Yoon, M.D
      • Sub-Investigator: Mong Cho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A. 24 weeks in RVR patients.; Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.	Drug: Peginterferon alfa-2a and Ribavirin; PegIFN alfa-2a (PEgasys) 180 ug/week; Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day); Treatment duration: 16 weeks; Drug: Peginterferon alfa-2a and Ribavirin; PegIFN alfa-2a (PEgasys) 180 ug/week; Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day); Treatment duration: 24 weeks
Experimental: B. 16 weeks in RVR patients.; Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.	Drug: Peginterferon alfa-2a and Ribavirin; PegIFN alfa-2a (PEgasys) 180 ug/week; Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day); Treatment duration: 16 weeks; Drug: Peginterferon alfa-2a and Ribavirin; PegIFN alfa-2a (PEgasys) 180 ug/week; Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day); Treatment duration: 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sustained virologic response (SVR)	24 weeks post-treatment (week 40 or week 48)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit
laboratory parameters	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit
vital signs	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Pusan National University Hospital; Inje University; Severance Hospital; Soon Chun Hyang University; Incheon St.Mary's Hospital; Inje University Ilsan Paik Hospital
• Investigators: Principal Investigator: Ki Tae Yoon, M.D, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Chronic hepatitis C; Ribavirin; Genotype 2; Sustained virologic response; Peginterferon alfa-2a; Rapid virologic response
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Immunologic Factors; Interferon-alpha; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: PNUYH-CHC001