We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Safety and Effectiveness of Sovaldi Treatment Regimens in Patients With Chronic Hepatitis C Virus (HCV) Infection in a Korean Real-World Setting

This study is currently recruiting participants.
Verified November 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907996
First Posted: September 20, 2016
Last Update Posted: November 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug Safety (MFDS).

Condition Intervention
Hepatitis C Virus Drug: Sofosbuvir

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Sovaldi Treatment Regimens in Patients With Chronic Hepatitis C Virus (HCV) Infection in a Korean Real-World Setting

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens [ Time Frame: Up to 30 days Posttreatment ]
  • Proportion of Patients with HCV RNA < Lower Limit of Quantification (LLOQ) [ Time Frame: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment ]

Secondary Outcome Measures:
  • Incidence of AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens [ Time Frame: Up to 12 weeks Posttreatment ]

Estimated Enrollment: 3000
Actual Study Start Date: September 9, 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sofosbuvir
Adult Korean patients with genotype 1, 2, 3, or 4 chronic HCV infection who are initiating commercial sofosbuvir regimens
Drug: Sofosbuvir
400 mg tablet administered orally once daily
Other Name: Sovaldi ®

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Korean patients with Genotype 1, 2, 3, and 4 chronic HCV infection who are initiating Sovaldi treatment regimen for the treatment of their HCV infection.
Criteria

Key Inclusion Criteria:

  • Patients aged 18 years and older who are living in Korea
  • Patients with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi.
  • Patients who have been informed of all pertinent aspects of the study and have voluntarily signed an informed consent form

Key Exclusion Criteria:

  • Patients treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea
  • Patients who have a contra-indication (refer to the Korea prescribing information)
  • Patients who have a contra-indication to ribavirin or peginterferon alfa or Daklinza
  • Pregnant or breast feeding women
  • Patients who have previously been administered Sovaldi
  • Patients participating in a concurrent HCV clinical trial
  • Patients planning on leaving the country during the study period

Note: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
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): NCT02907996


Contacts
Contact: Gilead Study Team GS-US-334-1967@gilead.com

  Show 73 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02907996     History of Changes
Other Study ID Numbers: GS-US-334-1967
First Submitted: September 16, 2016
First Posted: September 20, 2016
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents