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In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure
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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 -
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir + Ribavirin 1 | Active Comparator | Sofosbuvir + Ribavirin x 24 weeks |
|
| Sofosbuvir + Ribavirin 2 | Experimental | Sofosbuvir + Ribavirin x 36 weeks |
|
| Sofosbuvir + Ribavirin 3 | Experimental | Sofosbuvir + Ribavirin x 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir + Ribavirin 1 | Drug |
| ||
| Sofosbuvir + Ribavirin 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs. | 3 years | |
| Mortality at 6 months post therapy in all the 3 groups. | 48 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ankur Jindal, DM | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Drug |
|
| Sofosbuvir + Ribavirin 3 | Drug |
|
| 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 |
| Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups. | 48 weeks |
| Reduction in HVPG >20% to baseline after 1 year in all the 3 groups. | 48 weeks |
| SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification) | 24 weeks |
| SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification) | 36 weeks |
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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