None listed
Conditions
Interventions
Intervention1: interferon and Ribavirin: [Interferon a 2b 3MU/d and Ribavirin 1000mg/d
Control Intervention1: Interferon and glycyrrhizin: Interferon a2b 3 MU/d and Glycyrrhizin 250mg
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: AL T > 60 IU / L Histological activity index (HAl) > 3 Willing to be treated on an out-patient basis for 24 weeks Willing to give blood specimens initially, on days 2, 4 & 8 and subsequently at 4-weekly intervals during 24-wk treatment period and once in 12 weeks during the 24-wk follow-up period Willing to undergo liver biopsies thrice i.e., initially, at week 24 (optional) and after completion of F. U (week 48) Etiology of HCV
Exclusion criteria
Exclusion criteria: Fibrosis score> 5 (as per Knodell's scoring system) Serum bilirubin >3.0 mg% Prothrombin time 6 seconds prolonged than control Coronary artery, respiratory or any other disease with expected survival less than one year Major depressive illness, cytopenias, hyperthyroidism, renal transplantation, and evidence of auto-immune disease, Wilson's disease or co-infection with HIV Multiple transfusions like thalassemics and haemophiliacs Use of intravenous or oral narcotic drugs Receiving immuno-suppressive therapy for other associated illnesses Interferon therapy during the past 6 months Use of known hepatotoxic drugs, oral contraceptives, herbal medicines or cortico-steroids during the past 3 months Alcoholism [2 drinks (80 gm) per day for more than one year] Pregnancy Lactating mother with infant aged less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical Response: AL T Sustained response: Normal from the end of Rx till the end of follow-up (F.U.) Partial response: Normal during Rx or at the end of Rx and gets elevated (1.5 times normal) during F.U. Break through response: Normal during Rx but gets elevated before end of Rx. No response: Fails to normalize during Rx. Timepoint: As above;Biochemical,histopathological and virological Timepoint: Biochemical at 0 day,4,24,28 &48 wks Histopathological at 0 day,48 wks Virological atDays 0,2,4,8 and at4,24,28,48 and 72 wks;Histological response: HAl Score : Improves by 2 points over pre-inclusion score Fibrosis stage : Improves by 1 point over pre-inclusion stageTimepoint: As above;Virological Response: HCV RNA Sustained response : Negative at the end of Rx and F.U Partial response : Negative during or at the end of Rx but reappears during F.U. Break through response : Negative during 4 to 12 weeks and becomes positive before the end Rx No response : Not negative during RxTimepoint: As above | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr. Dipali Mukherjee
Outcome results
None listed