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

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: SOF

• Registration Number: NCT02592057
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2015-11-30
• Primary Completion: 2017-11-30
• Study Completion: 2018-04-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (26)

Midas Institute of Gastro-enterology; 🇮🇳 Nagpur, Maharashtra, India

Nirmal Hospital Pvt. Ltd.; 🇮🇳 Surat, Gujarat, India

Artemis Hospital; 🇮🇳 Gurgaon, Haryana, India

BYL Nair Hospital & T N Medical College; 🇮🇳 Mumbai, India

Manipal Hospital; 🇮🇳 Bengaluru, Karnataka, India

M.V. Hospital and Research Centre; 🇮🇳 Lucknow, India

Institute of Post Graduate Medical Education And Research; 🇮🇳 Kolkata, West Bengal, India

Om Research Center, Om Surgical Center & Maternity Home; 🇮🇳 Varanasi, India

Marudhar Hospital; 🇮🇳 Jaipur, Rajasthan, India

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, UT, India

Global Hospitals & Health City; 🇮🇳 Chennai, Tamil Nadu, India

S.R. Kalla Memorial Gastro & General Hospital; 🇮🇳 Jaipur, Rajasthan, India

VGM Hospital; 🇮🇳 Coimbatore, Tamil Nadu, India

KGMU Medical College; 🇮🇳 Lucknow, Uttar Pradesh, India

Sanjivani Superspeciality Hospital Clinical Research Department; 🇮🇳 Ahmedabad, India

BGS global Hospitals; 🇮🇳 Bengaluru, Karnataka, India

Global Hospitals; 🇮🇳 Hyderabad, Andhra Pradesh, India

A.I.I.M.S.; 🇮🇳 New Delhi, Ansari Nagar, India

Lakeshore Hospital; 🇮🇳 Kochi, Kerala, India

Sri Ramachandra Medical College and Research; 🇮🇳 Chennai, India

SMS Medical College & Hospital; 🇮🇳 Jaipur, Rajasthan, India

Saviour Hospital; 🇮🇳 Ahmedabad, India

Aware Global Hospital; 🇮🇳 Hyderabad, India

K. R. M. Hospital & Research Centre; 🇮🇳 Lucknow, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, India

Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India