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

December 23, 2021 updated by: Gilead Sciences

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2033

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-Si, Korea, Republic of, 420-767
        • SoonChunHyang University Bucheon Hospital
      • Bucheon-si, Korea, Republic of, 14647
        • The Catholic University of Korea Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of
        • Busan Veterans Hospital
      • Busan, Korea, Republic of
        • Busan St. Mary's Hospital
      • Busan, Korea, Republic of
        • Maryknoll Medical Center
      • Busan, Korea, Republic of, 48775
        • BongSeng Memorial Hospital
      • Changwon, Korea, Republic of, 51394
        • Changwon Fatima Hospital
      • Cheonan, Korea, Republic of, 31116
        • Dankook University Hospital
      • Cheonan, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
      • Chuncheon-si, Korea, Republic of, 24253
        • Hallym University Chuncheon Sacred Heart Hospital
      • Chungju, Korea, Republic of, 27376
        • Konkuk University Chungju hospital
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook national university medical center Chil-Gok
      • Daejeon, Korea, Republic of, 301-723
        • Daejeon St. Mary's hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 35233
        • Daejeon Eulji Medical Center
      • Gangneung, Korea, Republic of, 25440
        • Gangneung Asan Hospital
      • Goyang, Korea, Republic of, 10475
        • Myongji Hospital
      • Goyang, Korea, Republic of, 10326
        • Dongguk University Ilsan Hospital
      • Goyang-si, Korea, Republic of, 10444
        • National Health Insurance Cooperation Ilsan Hospital
      • Gumi, Korea, Republic of, 39295
        • Kumi Cha Hospital
      • Guri, Korea, Republic of, 11923
        • Hanyang University GURI Hospital
      • Gwangjin-gu, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Gwangju, Korea, Republic of, 501-717
        • Chosun university hospital
      • Gwangju, Korea, Republic of, 61661
        • Kwangju Christian Hospital
      • Gyeongju, Korea, Republic of, 38067
        • Dongguk university gyeongju hospital
      • Hwaseong-si, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Iksan, Korea, Republic of, 54538
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Incheon, Korea, Republic of, 22711
        • Catholic Kwandong University International St. Mary's Hospital
      • Jeju-Si, Korea, Republic of, 63127
        • Cheju Halla General Hospital
      • Jeonju, Korea, Republic of, 54987
        • Presbyterian Medical Center
      • Jeonju-si, Korea, Republic of
        • Chonbuk National University Hospital
      • Jinju, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Hospital
      • Seoul, Korea, Republic of, 07061
        • Boramae Medical Center
      • Seoul, Korea, Republic of, 03830
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of, 05535
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Nowon Eulji Medical Center
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital
      • Suwon-si, Korea, Republic of, 41931
        • The Catholic university of Korea, St. Vincent's Hospital
      • Uijeongbu, Korea, Republic of, 11765
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Yongin, Korea, Republic of, 17046
        • Yongin Severance Hospital
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-d
      • Sungnam, Gyeonggi-d, Korea, Republic of, 463-712
        • CHA Bundang Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Korean individuals with Genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean individuals (aged 12 to <18 years) with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens.

Description

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/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Sofosbuvir
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi ®

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: First dose date up to 30 days posttreatment
First dose date up to 30 days posttreatment
Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)
Time Frame: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
2 weeks before Posttreatment Week 12 through Week 24 Posttreatment

Secondary Outcome Measures

Outcome 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
Time Frame: First dose date up to 12 weeks posttreatment
First dose date up to 12 weeks posttreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2016

Primary Completion (Actual)

December 9, 2021

Study Completion (Actual)

December 9, 2021

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-1967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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