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

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: Sofosbuvir

• Registration Number: NCT02907996
• Lead Sponsor: Gilead Sciences

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Status Verified: 2021-12
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2033

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/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sofosbuvir	Sofosbuvir	Adult Korean participants with genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean participants aged 12 to \<18 years with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (71)

Yonsei University Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Sungnam, Gyeonggi-d, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

The Catholic University of Korea Bucheon ST. Mary's Hospital; 🇰🇷 Bucheon-si, Korea, Republic of

SoonChunHyang University Bucheon Hospital; 🇰🇷 Bucheon-Si, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

BongSeng Memorial Hospital; 🇰🇷 Busan, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

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