HCV Related Cirrhosis Clinical Trial
Official title:
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
| Verified date | January 2016 |
| Source | Institute of Liver and Biliary Sciences, India |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated
HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary
Sciences hospital will be included and those patients meeting the entry criteria received
treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin
administered orally twice daily, with doses determined according to body weight(600 mg daily
in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg,
and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration,
patients would be randomized in either of the 3 treatment groups -
- Group 1 - Sofosbuvir + Ribavirin x 24 weeks
- Group 2 - Sofosbuvir + Ribavirin x 36 weeks
- Group 3 - Sofosbuvir + Ribavirin x 48 weeks
| Status | Terminated |
| Enrollment | 62 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Male or Female = 18 yrs - Baseline HCV RNA > 1000 IU/ml - Cirrhosis with current or prior decompensation - HCV (Hepatitis C Infection) Genotype 3 - Treatment naïve or treatment experienced Exclusion Criteria: - HIV or HBV (Hepatitis B Virus) co-infection - Recent Variceal bleed - Pregnancy - Haemolytic anaemia - Platelet counts <20,000/ml - Advanced HCC (Hepatocellular Carcinoma) - Renal dysfunction, GFR (glomerular filtration rate) < 30 ml/min - Haemoglobin < 10 g/dl - MELD (Model for End Stage Liver Disease) >25, CTP (Child-Turcotte-Pugh score) >12 - Post organ transplant |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification) | 48 weeks | ||
| Secondary | The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs. | 3 years | ||
| Secondary | Mortality at 6 months post therapy in all the 3 groups. | 48 weeks | ||
| Secondary | Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year. | 48 weeks | ||
| Secondary | Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups. | 48 weeks | ||
| Secondary | Reduction in HVPG >20% to baseline after 1 year in all the 3 groups. | 48 weeks | ||
| Secondary | SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification) | 24 weeks | ||
| Secondary | SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification) | 36 weeks |