Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
- Conditions
- Hepatitis C Virus
- Interventions
- Drug: SOF
- Registration Number
- NCT02592057
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
- HCV-infected patients living in India
- Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.
- Patients who provide written and signed informed consent prior to initiation of treatment where required.
- Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
- Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SOF-based regimens SOF Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen Up to Posttreatment Week 4
- Secondary Outcome Measures
Name Time Method Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12) Posttreatment Week 12 SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively.
Trial Locations
- Locations (26)
Global Hospitals
🇮🇳Hyderabad, Andhra Pradesh, India
A.I.I.M.S.
🇮🇳New Delhi, Ansari Nagar, India
Nirmal Hospital Pvt. Ltd.
🇮🇳Surat, Gujarat, India
Artemis Hospital
🇮🇳Gurgaon, Haryana, India
Manipal Hospital
🇮🇳Bengaluru, Karnataka, India
BGS global Hospitals
🇮🇳Bengaluru, Karnataka, India
Lakeshore Hospital
🇮🇳Kochi, Kerala, India
Midas Institute of Gastro-enterology
🇮🇳Nagpur, Maharashtra, India
S.R. Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, Rajasthan, India
SMS Medical College & Hospital
🇮🇳Jaipur, Rajasthan, India
Scroll for more (16 remaining)Global Hospitals🇮🇳Hyderabad, Andhra Pradesh, India