Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783976
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment
HCV Infection Drug: Sovaldi

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Actual Study Start Date : October 28, 2016
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
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.
Drug: Sovaldi
Sovaldi 400 mg tablets administered orally once daily
Other Names:
  • Sofosbuvir
  • GS-7977




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to Posttreatment Week 4 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 24 weeks ]
  2. 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 [ Time Frame: Up to Posttreatment Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with chronic HCV infection living in Mexico who take SOF as part of routine clinical care at a participating clinical site.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783976


Locations
Layout table for location information
Mexico
Cuernavaca, Mexico
Durango, Mexico
Guadalajara, Mexico, 44680
Guadalajara, Mexico
Mexico City, Mexico
Monterrey, Mexico, 64460
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02783976     History of Changes
Other Study ID Numbers: GS-US-334-1685
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Hepatitis C
Hepatitis C, Chronic
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents