A clinical trial to study safety and efficacy of Sofosbuvir and Velpatasvir fixed dose combination in adult Indian patients with HCV infections
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis C
- Registration Number
- CTRI/2018/08/015359
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 408
1. Willing and able to provide written informed consent.
2. Male or female, age >= 18 years.
3. Body mass index (BMI) >= 18 kg/m2
4. Confirmed chronic HCV infection.
5. Eligible to receive sofosbuvir/ velpatasvir fixed dose combination in HCV infection
6. Without clinically significant ECG abnormalities.
7. Having Child-Pugh Score <10
1. Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
2. Chronic liver disease of a non-HCV etiology
3. Known co-infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
4. Documented or suspected Hepatocellular Carcinoma (HCC)
5. Evidence of Hepatic decompensation.
6. Patients with Hemoglobin <= 8.5 g/dL (5.27 mmol/L).
7. Patients with severe renal impairment
8. Patients who are on medication that can cause bradycardia.
9. History of treatment failure to a sofosbuvir based regimen
10. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ velpatasvir based combination therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of sofosbuvir/velpatasvir FDC in Adults with Chronic HCV infection up to 12 weeks after End of Treatment.Timepoint: Safety and tolerability of sofosbuvir/velpatasvir FDC in Adults with Chronic HCV infection up to 12 weeks after End of Treatment.
- Secondary Outcome Measures
Name Time Method Sustained Virologic ResponseTimepoint: 12 weeks after end of treatment