Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea

A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02907996

Enrollment

2033

Registered

2016-09-20

Start date

2016-09-09

Completion date

2021-12-09

Last updated

2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

Brief summary

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).

Interventions

DRUGSofosbuvir

400 mg tablet administered orally once daily

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Individuals aged 12 years and older who are living in Korea * Individuals with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi * Individuals who have been informed of all pertinent aspects of the study and have voluntarily signed Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have their legally authorized representatives sign the PIPA consent form Key

Exclusion criteria

* Individuals treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea * Individuals who have a contra-indication (refer to the Korea prescribing information) * Individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir * Pregnant or breast feeding women * Individuals who have previously been administered Sovaldi * Individuals participating in a concurrent HCV clinical trial * Individuals planning on leaving the country during the study period Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Experiencing Any Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens	First dose date up to 30 days posttreatment
Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)	2 weeks before Posttreatment Week 12 through Week 24 Posttreatment

Secondary

Measure	Time frame
Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens	First dose date up to 12 weeks posttreatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026