Status:
UNKNOWN
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
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
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 impo...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Serum Hepatitis C RNA \> 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01441804
Start Date
May 1 2011
End Date
August 1 2014
Last Update
October 1 2013
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China, 510630
2
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
3
Panyu People's Hospital
Guangzhou, Guangdong, China
4
Zhongshan second people's hospital
Zhongshan, Guangdong, China