PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Peginterferon alfa-2a and Ribavirin
Peginterferon alfa-2a and Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Genotype 2, Rapid virologic response, Sustained virologic response, Peginterferon alfa-2a, Ribavirin
Eligibility Criteria
Inclusion Criteria:
- Age older than 18 years old
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum quantitative HCV-RNA
- HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Exclusion Criteria:
- Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
- 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)
- Decompensated liver disease (Child-Pugh class B or C)
- Neoplastic disease within 5 years
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Women with ongoing pregnancy or breast feeding
- Hgb < 11 g/dL in women or < 12 g/dL in men at screening
- Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
- Serum creatinine level > 1.5 times the upper limit of normal at screening
- Serum alpha-fetoprotein > 100 ng/mL
- 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
- 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
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- History of a severe seizure disorder or current anticonvulsant use
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Sites / Locations
- Pusan National University Yangsan HospitalRecruiting
- Soon Chun Hyang University Bucheon HospitalRecruiting
- Pusan National University HospitalRecruiting
- Inje University Pusan Paik HospitalRecruiting
- Inje University Haeundae Paik HospitalRecruiting
- Inje University Ilsan Paik Hospital
- Incheon St. Mary's HospitalRecruiting
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A. 24 weeks in RVR patients.
B. 16 weeks in RVR patients.
Arm Description
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.
Outcomes
Primary Outcome Measures
Sustained virologic response (SVR)
Secondary Outcome Measures
AEs
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
laboratory parameters
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
vital signs
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
Full Information
NCT ID
NCT01056172
First Posted
January 25, 2010
Last Updated
April 18, 2012
Sponsor
Pusan National University Yangsan Hospital
Collaborators
Severance Hospital, Pusan National University Hospital, Incheon St.Mary's Hospital, Soon Chun Hyang University, Inje University, Inje University Ilsan Paik Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01056172
Brief Title
PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
Collaborators
Severance Hospital, Pusan National University Hospital, Incheon St.Mary's Hospital, Soon Chun Hyang University, Inje University, Inje University Ilsan Paik Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic hepatitis C, Genotype 2, Rapid virologic response, Sustained virologic response, Peginterferon alfa-2a, Ribavirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A. 24 weeks in RVR patients.
Arm Type
Active Comparator
Arm Description
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.
Arm Title
B. 16 weeks in RVR patients.
Arm Type
Experimental
Arm Description
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a and Ribavirin
Intervention Description
PegIFN alfa-2a (PEgasys) 180 ug/week
Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
Treatment duration: 16 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a and Ribavirin
Intervention Description
PegIFN alfa-2a (PEgasys) 180 ug/week
Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
Treatment duration: 24 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR)
Time Frame
24 weeks post-treatment (week 40 or week 48)
Secondary Outcome Measure Information:
Title
AEs
Description
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
Time Frame
up to 24 weeks after last treatment visit
Title
laboratory parameters
Description
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
Time Frame
up to 24 weeks after last treatment visit
Title
vital signs
Description
16 weeks treatment arm: 40 weeks
24 weeks treatment arm: 48 weeks
Time Frame
up to 24 weeks after last treatment visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age older than 18 years old
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Detectable serum quantitative HCV-RNA
HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Exclusion Criteria:
Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
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)
Decompensated liver disease (Child-Pugh class B or C)
Neoplastic disease within 5 years
Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
Women with ongoing pregnancy or breast feeding
Hgb < 11 g/dL in women or < 12 g/dL in men at screening
Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
Serum creatinine level > 1.5 times the upper limit of normal at screening
Serum alpha-fetoprotein > 100 ng/mL
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
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
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
History of a severe seizure disorder or current anticonvulsant use
Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Tae Yoon, M.D
Phone
+82-55-360-2362
Email
ktyoon@pusan.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Yoon, M.D
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongnam
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Tae Yoon, M.D
Phone
+82-55-360-2362
Email
ktyoon@pusan.ac.kr
First Name & Middle Initial & Last Name & Degree
Ki Tae Yoon, M.D
First Name & Middle Initial & Last Name & Degree
Mong Cho
Facility Name
Soon Chun Hyang University Bucheon Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim
Phone
82-10-6360-2635
Email
liverkys@schbc.ac.kr
First Name & Middle Initial & Last Name & Degree
Young Seok Kim
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Heo, M.D, Ph.D
Phone
+82-51-240-7869
Email
jheo@pusan.ac.kr
First Name & Middle Initial & Last Name & Degree
Jeong Heo, M.D, Ph.D
First Name & Middle Initial & Last Name & Degree
Hyun Young Woo
Facility Name
Inje University Pusan Paik Hospital
City
Busan
ZIP/Postal Code
633-165
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youn Jae Lee
Phone
08-10-7747-9281
Email
yjyh0105@inje.ac.kr
First Name & Middle Initial & Last Name & Degree
Eun Uk Jung
First Name & Middle Initial & Last Name & Degree
Youn Jae Lee
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Ha Park, M.D.
Phone
+82-10-4718-4545
Email
obgyy@medimail.co.kr
First Name & Middle Initial & Last Name & Degree
Seung Ha Park, M.D.
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Won Jang
Phone
82-11-204-9400
Email
garden@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Jeong Woon Jang
First Name & Middle Initial & Last Name & Degree
Jung Hyun Kwon
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yong Park, M.D
Phone
+82-10-8353-0670
Email
drpjy@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Jun Yong Park, M.D
12. IPD Sharing Statement
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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)
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