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

Overview

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.

Full Title of Study: “A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2017

Interventions

  • Drug: SOF
    • SOF tablets administered orally once daily based on approved prescribing information

Arms, Groups and Cohorts

  • SOF-based regimens
    • Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
    • Time Frame: Up to Posttreatment Week 4

Secondary Measures

  • Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gilead Study Director, Study Director, Gilead Sciences

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