A clinical trial to study Safety and effectiveness of sofosbuvir, ledipasvir and daclatasvir in HCV patients
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis C
- Registration Number
- CTRI/2018/04/013390
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 501
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 GT 1 or 3 infection.
5. Eligible to receive ledipasvir/sofosbuvir fixed dose combination if GT 1 and eligible to receive sofosbuvir and daclatasvir combination therapy if GT 3
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 (eg, hemochromatosis, Wilsonâ??s disease, alpha 1 antitrypsin deficiency, cholangitis)
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 (eGFR <45 mL/min/1.73 m2) or ESRD requiring haemodialysis.
8. Patients who are on medication that can cause bradycardia.
9. History of treatment failure to a sofosbuvir based regimen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of MyHep LVIRTM in chronic HCV Genotype 1 infection and of MyHepTM and MyDeklaTM combination therapy, with or without ribavirin, in chronic HCV GT 3 infectionTimepoint: 12 weeks after the end of treatment
- Secondary Outcome Measures
Name Time Method Sustained Virologic ResponseTimepoint: 12 weeks after end of treatment
Related Research Topics
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