Clinical trial NCT02592057: Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
timeFrame: Up to Posttreatment Week 4
Secondary outcomes:
measure: Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
timeFrame: Posttreatment Week 12
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Global Hospitals
state: Andhra Pradesh
city: New Delhi
country: India
facility: A.I.I.M.S.
state: Ansari Nagar
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
state: Gujarat
city: Gurgaon
country: India
facility: Artemis Hospital
state: Haryana
city: Bengaluru
country: India
facility: Manipal Hospital
state: Karnataka
city: Bengaluru
country: India
facility: BGS global Hospitals
state: Karnataka
city: Kochi
country: India
facility: Lakeshore Hospital
state: Kerala
city: Nagpur
country: India
facility: Midas Institute of Gastro-enterology
state: Maharashtra
city: Jaipur
country: India
facility: S.R. Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Jaipur
country: India
facility: SMS Medical College & Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Marudhar Hospital
state: Rajasthan
city: Chennai
country: India
facility: Global Hospitals & Health City
state: Tamil Nadu
city: Coimbatore
country: India
facility: VGM Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: KGMU Medical College
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
state: UT
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education And Research
state: West Bengal
city: Ahmedabad
country: India
facility: Sanjivani Superspeciality Hospital Clinical Research Department
city: Ahmedabad
country: India
facility: Saviour Hospital
city: Chennai
country: India
facility: Sri Ramachandra Medical College and Research
city: Hyderabad
country: India
facility: Aware Global Hospital
city: Lucknow
country: India
facility: M.V. Hospital and Research Centre
city: Lucknow
country: India
facility: K. R. M. Hospital & Research Centre
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mumbai
country: India
facility: BYL Nair Hospital & T N Medical College
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Varanasi
country: India
facility: Om Research Center, Om Surgical Center & Maternity Home
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: