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

HCV Infection Clinical Trial

Official title:

A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783976
• Other study ID #: GS-US-334-1685
• Status: Completed
• Start date: October 28, 2016
• Est. completion date: June 20, 2018

Study information

• Verified date: September 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Communicable Diseases
• HCV Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• Sovaldi
Sovaldi 400 mg tablets administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period		Up to Posttreatment Week 4
Secondary	Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice		Up to 24 weeks
Secondary	Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment		Up to Posttreatment Week 24