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
1 other identifier
observational
532
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2018
CompletedMay 15, 2018
May 1, 2018
2 years
October 29, 2015
May 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
Posttreatment Week 12
Study Arms (1)
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.
Interventions
SOF tablets administered orally once daily based on approved prescribing information
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (26)
Global Hospitals
Hyderabad, Andhra Pradesh, 500 004, India
A.I.I.M.S.
New Delhi, Ansari Nagar, 110029, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002, India
Artemis Hospital
Gurgaon, Haryana, 122001, India
Manipal Hospital
Bengaluru, Karnataka, 560017, India
BGS global Hospitals
Bengaluru, Karnataka, 560098, India
Lakeshore Hospital
Kochi, Kerala, 682040, India
Midas Institute of Gastro-enterology
Nagpur, Maharashtra, 440 010, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Marudhar Hospital
Jaipur, Rajasthan, 302012, India
Global Hospitals & Health City
Chennai, Tamil Nadu, 600100, India
VGM Hospital
Coimbatore, Tamil Nadu, 641 005, India
KGMU Medical College
Lucknow, Uttar Pradesh, 226003, India
Postgraduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012, India
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, 700 020, India
Sanjivani Superspeciality Hospital Clinical Research Department
Ahmedabad, 380015, India
Saviour Hospital
Ahmedabad, 380015, India
Sri Ramachandra Medical College and Research
Chennai, 600116, India
Aware Global Hospital
Hyderabad, 500035, India
M.V. Hospital and Research Centre
Lucknow, 226003, India
K. R. M. Hospital & Research Centre
Lucknow, 226010, India
Dayanand Medical College & Hospital
Ludhiana, 144001, India
BYL Nair Hospital & T N Medical College
Mumbai, 400008, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Om Research Center, Om Surgical Center & Maternity Home
Varanasi, 221007, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
October 30, 2015
Study Start
November 30, 2015
Primary Completion
November 30, 2017
Study Completion
April 23, 2018
Last Updated
May 15, 2018
Record last verified: 2018-05