Back to resultsA Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Peginterferon alfa2a
Ribavirin
Peginterferon alfa2a
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
Exclusion Criteria:
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
Contraindications to PR-based treatment:
- Uncontrolled psychiatric illness
- Active substance dependency
- Known autoimmune disorder
- Untreated thyroid disease
- Uncontrolled seizure disorder
- Pregnancy, lactation or inability to maintain contraception
- Chronic kidney disease w/ estimated GFR< 60
- ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
Clinical or biochemical evidence of decompensated liver disease including:
- History of encephalopathy
- Ascites
- Variceal bleeding
- Bilirubin > 3g/dl or INR > 1.5
- Life threatening disorder with expected median survival less than 5 years
- Inability to comply with drug regimens or testing schedule required for study
Sites / Locations
- The Eighth People's Hospital of GuangzhouRecruiting
- The Third Affliated Hospital of Sun Yat-sen UniversityRecruiting
- Panyu People's HospitalRecruiting
- Zhongshan second people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
24-Week treatment group
48-Week treatment group
Arm Description
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
Outcomes
Primary Outcome Measures
Sustained virological response (SVR)
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
Secondary Outcome Measures
Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment
Full Information
NCT ID
NCT01441804
First Posted
September 24, 2011
Last Updated
September 28, 2013
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01441804
Brief Title
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
24-Week treatment group
Arm Type
Experimental
Arm Description
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks
Arm Title
48-Week treatment group
Arm Type
Active Comparator
Arm Description
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa2a
Intervention Description
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa2a
Intervention Description
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Primary Outcome Measure Information:
Title
Sustained virological response (SVR)
Description
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
Time Frame
24 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
Time Frame
baseline, 24 weeks after the end of treatment
Title
Sick leave in patients treated for 24 or 48 weeks treatment
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Serum Hepatitis C RNA > 10,000IU/mL
Hepatitis C virus genotype 1
IL28B CC polymorphism
Exclusion Criteria:
Previous treatment for chronic Hepatitis C
clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
Contraindications to PR-based treatment:
Uncontrolled psychiatric illness
Active substance dependency
Known autoimmune disorder
Untreated thyroid disease
Uncontrolled seizure disorder
Pregnancy, lactation or inability to maintain contraception
Chronic kidney disease w/ estimated GFR< 60
ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
Clinical or biochemical evidence of decompensated liver disease including:
History of encephalopathy
Ascites
Variceal bleeding
Bilirubin > 3g/dl or INR > 1.5
Life threatening disorder with expected median survival less than 5 years
Inability to comply with drug regimens or testing schedule required for study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cai Qingxian, doctor
Phone
+86013760857996
Email
cqx200000@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Zhixin, doctor
Phone
+86013527873714
Email
zxzhao@21cn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao Zhiliang, Doctor
Organizational Affiliation
The Third Affliated Hospital of Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhao Zhixin, Doctor
Organizational Affiliation
The Third Affliated Hospital of Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhang Xiaohong, Doctor
Organizational Affiliation
The Third Affliated Hospital of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eighth People's Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Fengjuan, Doctor
Phone
13416167557
Email
fengjuandj@163.com
First Name & Middle Initial & Last Name & Degree
Xu Min, doctor
Facility Name
The Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cai Qingxian, doctor
Phone
13760857996
Email
Cqx200000@163.com
First Name & Middle Initial & Last Name & Degree
Zhang Xiaohong, Doctor
First Name & Middle Initial & Last Name & Degree
Lin Chaoshuang, doctor
Facility Name
Panyu People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang mingshou, Bachelor
Phone
+86013711033556
First Name & Middle Initial & Last Name & Degree
Huang mingshou, Bachelor
Facility Name
Zhongshan second people's hospital
City
Zhongshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei min, Doctor
Phone
+86013702528182
First Name & Middle Initial & Last Name & Degree
Wei min, doctor
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
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