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
NCT ID: NCT01441804
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2011-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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24-Week treatment group
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
Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
48-Week treatment group
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
Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Interventions
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Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* Serum Hepatitis C RNA \> 10,000IU/mL
* Hepatitis C virus genotype 1
* IL28B CC polymorphism
Exclusion Criteria
* 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
16 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Cai Qingxian
Third Affiliated Hospital, Sun Yat-Sen University
Principal Investigators
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Gao Zhiliang, Doctor
Role: STUDY_CHAIR
The Third Affliated Hospital of Sun Yat-sen University
Zhao Zhixin, Doctor
Role: STUDY_DIRECTOR
The Third Affliated Hospital of Sun Yat-sen University
Zhang Xiaohong, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Third Affliated Hospital of Sun Yat-sen University
Locations
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The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Panyu People's Hospital
Guangzhou, Guangdong, China
Zhongshan second people's hospital
Zhongshan, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Chen Fengjuan, Doctor
Role: primary
Cai Qingxian, doctor
Role: primary
Huang mingshou, Bachelor
Role: primary
Wei min, Doctor
Role: primary
Other Identifiers
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TAHG1IL-28BCC
Identifier Type: -
Identifier Source: org_study_id