Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: LDV/SOF

• Registration Number: NCT02951364
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Study Start: 2016-12-05
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1081

Inclusion Criteria

• Individuals aged 12 years and older who are living in Korea
• Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form

Key

Exclusion Criteria

• Individuals treated with Harvoni outside of the approved prescribing information in Korea
• Individuals who have a contra-indication to Harvoni
• Individuals who have a contra-indication to ribavirin
• Pregnant or breastfeeding women
• Individuals who have previously been administered Harvoni
• 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
LDV/SOF	LDV/SOF	Adult Korean participants and pediatric Korean participants aged 12 to \<18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)	Up to 30 days following treatment	Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA \< lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as "improved/success" when HCV RNA \< LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)	Up to Posttreatment Week 12	Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.

Trial Locations

Locations (71)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggido, Korea, Republic of

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

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

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

Bumin Hospital Haeundae; 🇰🇷 Busan, Korea, Republic of

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

Good Gang-An Hospital; 🇰🇷 Busan, Korea, Republic of

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

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

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

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