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
1 other identifier
interventional
200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 24, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 1, 2013
September 1, 2013
3 years
September 24, 2011
September 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virological response (SVR)
Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment
24 weeks after the end of treatment
Secondary Outcomes (2)
Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
baseline, 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment
48 weeks
Study Arms (2)
24-Week treatment group
EXPERIMENTALGenotype 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
48-Week treatment group
ACTIVE COMPARATORGenotype 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
Interventions
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Serum Hepatitis C RNA \> 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, 510630, China
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Panyu People's Hospital
Guangzhou, Guangdong, China
Zhongshan second people's hospital
Zhongshan, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gao Zhiliang, Doctor
The Third Affliated Hospital of Sun Yat-sen University
- STUDY DIRECTOR
Zhao Zhixin, Doctor
The Third Affliated Hospital of Sun Yat-sen University
- PRINCIPAL INVESTIGATOR
Zhang Xiaohong, Doctor
The Third Affliated Hospital of Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Third Affiliated Hospital, Sun Yat-Sen University
Study Record Dates
First Submitted
September 24, 2011
First Posted
September 28, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
October 1, 2013
Record last verified: 2013-09