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Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India

Completed
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
GroupInterventionDescription
SOF-based regimensSOFAdults 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
NameTimeMethod
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimenUp to Posttreatment Week 4
Secondary Outcome Measures
NameTimeMethod
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

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