Clinical trial on Hepatitis C

Phase 3

Completed

• Registration Number: CTRI/2008/091/000105
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 125

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified