Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

NCT ID: NCT02783976

Last Updated: 2018-10-02

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

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-28

Study Completion Date

2018-06-20

Brief Summary

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This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.

Detailed Description

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Conditions

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HCV Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sovaldi-based regimens

Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site.

Sovaldi

Intervention Type DRUG

Sovaldi 400 mg tablets administered orally once daily

Interventions

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Sovaldi

Sovaldi 400 mg tablets administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Sofosbuvir GS-7977

Eligibility Criteria

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Inclusion Criteria

* HCV-infected patients living in Mexico
* Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician

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 prior to their SVR12 visit)
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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Cuernavaca, , Mexico

Site Status

Durango, , Mexico

Site Status

Guadalajara, , Mexico

Site Status

Guadalajara, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Monterrey, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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GS-US-334-1685

Identifier Type: -

Identifier Source: org_study_id

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