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

NCT ID: NCT02592057

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-04-23

Brief Summary

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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

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Conditions

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Hepatitis C Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

SOF

Intervention Type DRUG

SOF tablets administered orally once daily based on approved prescribing information

Interventions

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SOF

SOF tablets administered orally once daily based on approved prescribing information

Intervention Type DRUG

Other Intervention Names

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Sovaldi ® GS-7977

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Global Hospitals

Hyderabad, Andhra Pradesh, India

Site Status

A.I.I.M.S.

New Delhi, Ansari Nagar, India

Site Status

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, India

Site Status

Artemis Hospital

Gurgaon, Haryana, India

Site Status

Manipal Hospital

Bengaluru, Karnataka, India

Site Status

BGS global Hospitals

Bengaluru, Karnataka, India

Site Status

Lakeshore Hospital

Kochi, Kerala, India

Site Status

Midas Institute of Gastro-enterology

Nagpur, Maharashtra, India

Site Status

S.R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Site Status

SMS Medical College & Hospital

Jaipur, Rajasthan, India

Site Status

Marudhar Hospital

Jaipur, Rajasthan, India

Site Status

Global Hospitals & Health City

Chennai, Tamil Nadu, India

Site Status

VGM Hospital

Coimbatore, Tamil Nadu, India

Site Status

KGMU Medical College

Lucknow, Uttar Pradesh, India

Site Status

Postgraduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, India

Site Status

Institute of Post Graduate Medical Education And Research

Kolkata, West Bengal, India

Site Status

Sanjivani Superspeciality Hospital Clinical Research Department

Ahmedabad, , India

Site Status

Saviour Hospital

Ahmedabad, , India

Site Status

Sri Ramachandra Medical College and Research

Chennai, , India

Site Status

Aware Global Hospital

Hyderabad, , India

Site Status

M.V. Hospital and Research Centre

Lucknow, , India

Site Status

K. R. M. Hospital & Research Centre

Lucknow, , India

Site Status

Dayanand Medical College & Hospital

Ludhiana, , India

Site Status

BYL Nair Hospital & T N Medical College

Mumbai, , India

Site Status

Sir Ganga Ram Hospital

New Delhi, , India

Site Status

Om Research Center, Om Surgical Center & Maternity Home

Varanasi, , India

Site Status

Countries

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India

Other Identifiers

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GS-US-334-1775

Identifier Type: -

Identifier Source: org_study_id

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