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

May 14, 2018 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380015
        • Sanjivani Superspeciality Hospital Clinical Research Department
      • Ahmedabad, India, 380015
        • Saviour Hospital
      • Chennai, India, 600116
        • Sri Ramachandra Medical College and Research
      • Hyderabad, India, 500035
        • Aware Global Hospital
      • Lucknow, India, 226003
        • M.V. Hospital and Research Centre
      • Lucknow, India, 226010
        • K. R. M. Hospital & Research Centre
      • Ludhiana, India, 144001
        • Dayanand Medical College & Hospital
      • Mumbai, India, 400008
        • BYL Nair Hospital & T N Medical College
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • Varanasi, India, 221007
        • Om Research Center, Om Surgical Center & Maternity Home
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 004
        • Global Hospitals
    • Ansari Nagar
      • New Delhi, Ansari Nagar, India, 110029
        • A.I.I.M.S.
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt. Ltd.
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Artemis Hospital
    • Karnataka
      • Bengaluru, Karnataka, India, 560017
        • Manipal Hospital
      • Bengaluru, Karnataka, India, 560098
        • BGS Global Hospitals
    • Kerala
      • Kochi, Kerala, India, 682040
        • Lakeshore Hospital
    • Maharashtra
      • Nagpur, Maharashtra, India, 440 010
        • Midas Institute of Gastro-enterology
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Medical College & Hospital
      • Jaipur, Rajasthan, India, 302012
        • Marudhar Hospital
      • Jaipur, Rajasthan, India, 302001
        • S.R. Kalla Memorial Gastro & General Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600100
        • Global Hospitals & Health City
      • Coimbatore, Tamil Nadu, India, 641 005
        • VGM Hospital
    • UT
      • Chandigarh, UT, India, 160012
        • Postgraduate Institute of Medical Education and Research
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • KGMU Medical College
    • West Bengal
      • Kolkata, West Bengal, India, 700 020
        • Institute of Post Graduate Medical Education And Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults residing in India aged ≥ 18 years, who are infected with HCV, and for whom the treating physicians in the participating clinics have prescribed a SOF-based regimen as per the approved prescribing information.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: SOF
SOF tablets administered orally once daily based on approved prescribing information
Other Names:
  • GS-7977
  • Sovaldi ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to Posttreatment Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttreatment Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

April 23, 2018

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-1775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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