Clincosm LogoSign in Get a demo

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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02907996
Collaborator
(none)
2,033
Enrollment
72
Locations
63
Actual Duration (Months)
28.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2033 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
Actual Study Start Date :
Sep 9, 2016
Actual Primary Completion Date :
Dec 9, 2021
Actual Study Completion Date :
Dec 9, 2021

Arms and Interventions

Arm 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 ®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ) [2 weeks before Posttreatment Week 12 through Week 24 Posttreatment]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Wonju Severance Christian Hospital Wonju Gangwon-do Korea, Republic of 26426
    2 CHA Bundang Medical Center Sungnam Gyeonggi-d Korea, Republic of 463-712
    3 Hallym University Sacred Heart Hospital Anyang Korea, Republic of 14068
    4 The Catholic University of Korea Bucheon ST. Mary's Hospital Bucheon-si Korea, Republic of 14647
    5 SoonChunHyang University Bucheon Hospital Bucheon-Si Korea, Republic of 420-767
    6 Inje University Haeundae Paik Hospital Busan Korea, Republic of 48108
    7 BongSeng Memorial Hospital Busan Korea, Republic of 48775
    8 Dong-A University Hospital Busan Korea, Republic of 49201
    9 Pusan National University Hospital Busan Korea, Republic of 49241
    10 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    11 Inje University Busan Paik Hospital Busan Korea, Republic of 614-735
    12 Busan St. Mary's Hospital Busan Korea, Republic of
    13 Busan Veterans Hospital Busan Korea, Republic of
    14 Maryknoll Medical Center Busan Korea, Republic of
    15 Changwon Fatima Hospital Changwon Korea, Republic of 51394
    16 Dankook University Hospital Cheonan Korea, Republic of 31116
    17 SoonChunHyang University Cheonan Hospital Cheonan Korea, Republic of 31151
    18 Hallym University ChunCheon Sacred Heart Hospital Chuncheon-si Korea, Republic of 24253
    19 Konkuk University Chungju Hospital Chungju Korea, Republic of 27376
    20 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    21 Yeungnam University Medical Center Daegu Korea, Republic of 42415
    22 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472
    23 Kyungpook National University Hospital Daegu Korea, Republic of 700-721
    24 Kyungpook national university medical center Chil-Gok Daegu Korea, Republic of 700-721
    25 DaeJeon ST. Mary's Hospital Daejeon Korea, Republic of 301-723
    26 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    27 Daejeon Eulji Medical Center Daejeon Korea, Republic of 35233
    28 GangNeung Asan Hospital Gangneung Korea, Republic of 25440
    29 National Health Insurance Cooperation Ilsan Hospital Goyang-si Korea, Republic of 10444
    30 Dongguk University Ilsan Hospital Goyang Korea, Republic of 10326
    31 Myongji Hospital Goyang Korea, Republic of 10475
    32 Kumi Cha Hospital Gumi Korea, Republic of 39295
    33 Hanyang University Guri Hospital Guri Korea, Republic of 11923
    34 Konkuk University Medical Center Gwangjin-gu Korea, Republic of 05030
    35 Chosun University Hospital Gwangju Korea, Republic of 501-717
    36 Kwangju Christian Hospital Gwangju Korea, Republic of 61661
    37 Dongguk University Gyeongju Hospital Gyeongju Korea, Republic of 38067
    38 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Korea, Republic of
    39 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 58128
    40 WonKwang University Hospital Iksan Korea, Republic of 54538
    41 The Catholic University of Korea, Incheon St. Mary's Hospital Incheon Korea, Republic of 21431
    42 Inha University Hospital Incheon Korea, Republic of 22332
    43 Catholic Kwandong University International St. Mary's Hospital Incheon Korea, Republic of 22711
    44 Gachon University Gil Medical Center Incheon Korea, Republic of 405-760
    45 Cheju Halla General Hospital Jeju-Si Korea, Republic of 63127
    46 Chonbuk National University Hospital Jeonju-si Korea, Republic of
    47 Presbyterian Medical Center Jeonju Korea, Republic of 54987
    48 Gyeongsang National University Hospital Jinju Korea, Republic of 52727
    49 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    50 Korea University Anam Hospital Seoul Korea, Republic of 02841
    51 Seoul National University Hospital Seoul Korea, Republic of 03080
    52 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    53 Seoul National University Hospital Seoul Korea, Republic of 03830
    54 SoonChunHyang University Hospital Seoul Korea, Republic of 04401
    55 Hanyang University Hospital Seoul Korea, Republic of 04763
    56 Asan Medical Center Seoul Korea, Republic of 05505
    57 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 05535
    58 Chung-Ang University Hospital Seoul Korea, Republic of 06973
    59 Boramae Medical Center Seoul Korea, Republic of 07061
    60 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 07985
    61 Inje University Seoul Paik Hospital Seoul Korea, Republic of 100-032
    62 Severance Hospital Seoul Korea, Republic of 120-752
    63 Samsung Medical Center Seoul Korea, Republic of 135-710
    64 Korea University Guro Hospital Seoul Korea, Republic of 152-703
    65 Inje University Sanggye Paik Hospital Seoul Korea, Republic of
    66 Nowon Eulji Medical Center Seoul Korea, Republic of
    67 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Korea, Republic of 41931
    68 Ajou University Hospital Suwon Korea, Republic of 16499
    69 The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu Korea, Republic of 11765
    70 Ulsan University Hospital Ulsan Korea, Republic of 44033
    71 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 50612
    72 Yongin Severance Hospital Yongin Korea, Republic of 17046

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02907996
    Other Study ID Numbers:
    • GS-US-334-1967
    First Posted:
    Sep 20, 2016
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Sofosbuvir

    Study Results

    No Results Posted as of Dec 27, 2021