Clinical trial NCT02464631: To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HCV Related Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
timeFrame: 48 weeks
Secondary outcomes:
measure: The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
timeFrame: 3 years
measure: Mortality at 6 months post therapy in all the 3 groups.
timeFrame: 48 weeks
measure: 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.
timeFrame: 48 weeks
measure: Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
timeFrame: 48 weeks
measure: Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
timeFrame: 48 weeks
measure: SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
timeFrame: 24 weeks
measure: SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Ankur Jindal, DM
role: PRINCIPAL_INVESTIGATOR
References: