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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592057
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hepatitis C Virus Drug: SOF

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Study Type : Observational
Actual Enrollment : 532 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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:
  • Sovaldi ®
  • GS-7977




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592057


Locations
Show Show 26 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02592057    
Other Study ID Numbers: GS-US-334-1775
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents