Clinical trial on Hepatitis C

Phase 3

• Conditions: Hepatitis C

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

Brief Summary

This study is a Multi-centric randomized controlled trial comparing two treatment regimens [Interferon a 2b 3MU/d and Ribavirin 1000mg/d (I+R) vs. Interferon a2b 3 MU/d and Glycyrrhizin 250mg (I+G)] in CH-C. Viral, host characteristics and therapeutic responses were assessed.The study was carried out in twelve centres in India andperiod was February 2002 to May 2005. One hundred and thirty one patients meeting the inclusion criteria were randomized to I+G (n = 64) or I+R (n = 67). About 85% (I+G = 53, I+R = 58) completed 6 months of treatment and 99 (I+G = 46, I+R = 53) completed 6 months of follow-up after completion of treatment. HCV Genotype 3 was the major type detected (71%) in patients. The mean viral load (106 copies/ml), histological activity index and fibrosis stage for all patients were 0.59 + 0.93, 5 + 2 and 2 + 1.5 respectively. HCV infection with genotypes 1 and 4 was more prevalent among males than in females (33.8% vs. 8.3%); average BMI was more in patients with higher viral load than lower viral load (26.9 vs. 23.9 Kg/m2); more females than males (64.5% vs. 41.8%) and more patients aged > 40 years than aged < 40 years (58.9% vs. 32.1%) had fibrosis score &#8805; 3 (p < 0.01). The rapid viral response (RVR), end of treatment viral response (ETVR), sustained virological response (SVR) and histological improvement among the two treatment arms I+G and I+R by per-protocol (PP) analysis were 78.6% vs. 86.2%, 78.4% vs. 84.9%, 58.7% vs. 72.9% and 62.5% vs. 64.4% respectively (p > 0.19). I+G treatment is associated with lower frequencies of leucopenia (2% vs. 17%, p < 0.01) and decrease in hemoglobin (8% vs. 40%, p < 0.001) as compared to treatment with I+R.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 125

Inclusion Criteria

• AL T > 60 IU / LHistological activity index (HAl) > 3Willing to be treated on an out-patient basis for 24 weeksWilling 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 periodWilling 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 controlCoronary artery, respiratory or any other disease with expected survival less than one yearMajor depressive illness, cytopenias, hyperthyroidism, renal transplantation, and evidence of auto-immune disease, Wilson's disease or co-infection with HIVMultiple transfusions like thalassemics and haemophiliacsUse of intravenous or oral narcotic drugsReceiving immuno-suppressive therapy for other associated illnessesInterferon therapy during the past 6 monthsUse of known hepatotoxic drugs, oral contraceptives, herbal medicines or cortico-steroids during the past 3 monthsAlcoholism [2 drinks (80 gm) per day for more than one year]PregnancyLactating mother with infant aged less than 6 months.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical,histopathological and virological	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

Trial Locations

Locations (12)

AIIMS; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences, Ansari Nagar; 🇮🇳 Delhi, DELHI, India

Bombay Hospital & Medical Research Centre, 12, Marine Lines; 🇮🇳 Mumbai, MAHARASHTRA, India

Deccan College of Medical Sciences & Allied Hospital, Zafar Garh, Kanchanbagh; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

G.B.Pant Hospital; 🇮🇳 Delhi, DELHI, India

IGPMER; 🇮🇳 Kolkata, WEST BENGAL, India

MAMC; 🇮🇳 Delhi, DELHI, India

Metro Centre for Liver and Digestive Diseases L-94, Sector-11; 🇮🇳 India

National Institute of Epidemiology (ICMR), Mayor V.R.Ramanathan Road, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

National Institute of Virology, 20-A, Dr. Ambedkar Road; 🇮🇳 Pune, MAHARASHTRA, India

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AIIMS

🇮🇳Delhi, DELHI, India

DR. S K Acharya

Principal investigator

011-26589130

subratacharya2004@yahoo.com