Role of anti Hepatitis C drug (Sofosbuvir and Ribavirin)in Liver disease.
Phase 3
- Conditions
- Health Condition 1: null- Decompensated Hepatitis CHealth Condition 2: K740- Hepatic fibrosis
- Registration Number
- CTRI/2017/11/010373
- Lead Sponsor
- ATCO PHARMACEUTICALS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
ï?¼Male or Female >= 18 yrs
ï?¼Baseline HCV RNA > 1000 IU/ml
ï?¼Cirrhosis with current or prior decompensation
ï?¼HCV Genotype 3
�Treatment naïve or treatment experienced
Exclusion Criteria
ï?¼HIV or HBV co-infection
ï?¼Recent Variceal bleed
ï?¼Pregnancy
ï?¼Haemolytic anaemia
ï?¼Platelet counts <20,000/ml
ï?¼Advanced HCC
ï?¼Renal dysfunction, GFR < 30 ml/min
ï?¼Haemoglobin < 10 g/dl
ï?¼MELD >25, CTP >12
ï?¼Post organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary efficacy end point is SVR 24 defined as HCV RNA Lower Limit of Quantification 24 weeks after discontinuation of therapyTimepoint: 6 months post treatment
- Secondary Outcome Measures
Name Time Method Adverse Event leading to permanent discontinuation of study drugs.Timepoint: during the treatment period;Improvement in the liver function as determined by CTP, MELD more than 2 points at 6 months and 1 year.Timepoint: 6 months and 1 year;Mortality at 6 months post therapy in all the 3 groups.Timepoint: 6 months;Number of new cases of Hepatocellular Carcinoma at end of therapy.Timepoint: 6 months post therapy in all the 3 groups.;Reduction in HVPG 20% to baseline after 1 year in all the 3 groups.Timepoint: 1 year;SVR 12 defined as HCV RNA LLOQ 12 weeks after discontinuation of therapy.Timepoint: 12 weeks post therapy in all the 3 groups.;SVR 4 defined as HCV RNA LLOQ 4 weeks after discontinuation of therapy.Timepoint: 4 weeks post therapy in all the 3 groups.