Chronic Hepatitis C
Conditions
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.
Interventions
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
DRUGRibavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virological response (SVR) | 24 weeks after the end of treatment | Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactCai Qingxian, doctor
Backup ContactZhao Zhixin, doctor
Outcome results
None listed