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Completed

NCT Number: NCT02592057

Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of 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.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Global Hospitals, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SOF

Drug

SOF tablets administered orally once daily based on approved prescribing information

Other names: Sovaldi ®, GS-7977

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 30, 2015
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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