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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02592057

Enrollment

532

Registered

2015-10-30

Start date

2015-11-30

Completion date

2018-04-23

Last updated

2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

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.

Interventions

DRUGSOF

SOF tablets administered orally once daily based on approved prescribing information

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026