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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Pusan National University Yangsan Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Severance Hospital
Pusan National University Hospital
Incheon St.Mary's Hospital
Soon Chun Hyang University
Inje University
Information provided by (Responsible Party):
Ki Tae Yoon, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT01056172
First received: January 25, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Peginterferon alfa-2a and Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pusan National University Yangsan Hospital:

Primary Outcome Measures:
  • Sustained virologic response (SVR) [ Time Frame: 24 weeks post-treatment (week 40 or week 48) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs [ Time Frame: up to 24 weeks after last treatment visit ] [ Designated as safety issue: No ]
    1. 16 weeks treatment arm: 40 weeks
    2. 24 weeks treatment arm: 48 weeks

  • laboratory parameters [ Time Frame: up to 24 weeks after last treatment visit ] [ Designated as safety issue: No ]
    1. 16 weeks treatment arm: 40 weeks
    2. 24 weeks treatment arm: 48 weeks

  • vital signs [ Time Frame: up to 24 weeks after last treatment visit ] [ Designated as safety issue: No ]
    1. 16 weeks treatment arm: 40 weeks
    2. 24 weeks treatment arm: 48 weeks


Estimated Enrollment: 164
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  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
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
  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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056172

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

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

No publications provided

Responsible Party: Ki Tae Yoon, Assistant Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT01056172     History of Changes
Other Study ID Numbers: PNUYH-CHC001
Study First Received: January 25, 2010
Last Updated: April 18, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pusan National University Yangsan Hospital:
Chronic hepatitis C
Genotype 2
Rapid virologic response
Sustained virologic response
Peginterferon alfa-2a
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014