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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02951364
Collaborator
(none)
1,081
Enrollment
72
Locations
54.2
Actual Duration (Months)
15
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1081 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
Actual Study Start Date :
Dec 5, 2016
Actual Primary Completion Date :
Jun 11, 2021
Actual Study Completion Date :
Jun 11, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Drug: LDV/SOF
90/400 mg tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    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

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHA Bundang Medical Center Seongnam-si Gyeonggido Korea, Republic of 13496
    2 Hallym University Sacred Heart Hospital Anyang-si Korea, Republic of 14068
    3 SoonChunHyang University Bucheon Hospital Bucheon-si Korea, Republic of 14584
    4 The Catholic University of Korea Bucheon ST. Mary's Hospital Bucheon-si Korea, Republic of 14647
    5 Bumin Hospital Haeundae Busan Korea, Republic of 48094
    6 Inje University Haeundae Paik Hospital Busan Korea, Republic of 48108
    7 Good Gang-An Hospital Busan Korea, Republic of 48265
    8 Dong-A University Medical Center 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-si Korea, Republic of
    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 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    26 Konyang University Hospital Daejeon Korea, Republic of 35365
    27 GangNeung Asan Hospital Gangneung-si Korea, Republic of
    28 National Health Insurance Corporation Ilsan Hospital Goyang-si Korea, Republic of 10444
    29 Dongguk University Ilsan Hospital Goyang Korea, Republic of 10326
    30 Myongji Hospital Goyang Korea, Republic of 10475
    31 Kumi Cha Hospital Gumi Korea, Republic of 39295
    32 Chosun University Hospital Gwangju Korea, Republic of 501-717
    33 Kwangju Christian Hospital Gwangju Korea, Republic of
    34 Hanyang University Guri Hospital Gyeonggi-do Korea, Republic of 11923
    35 Dongguk University Gyeongju Hospital Gyeongju-si Korea, Republic of
    36 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Korea, Republic of
    37 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 58128
    38 WonKwang University Hospital Iksan Korea, Republic of 54538
    39 The Catholic University of Korea, Incheon St. Mary's Hospital Incheon Korea, Republic of 21431
    40 Inha University Hospital Incheon Korea, Republic of 22332
    41 Gachon University Gil Medical Center Incheon Korea, Republic of 405-760
    42 Cheju Halla General Hospital Jeju-si Korea, Republic of 63127
    43 Chonbuk National University Hospital Jeonju-si Korea, Republic of
    44 Presbyterian Medical Center Jeonju Korea, Republic of 54987
    45 Gyeongsang National University Hospital Jinju-si Korea, Republic of 660-702
    46 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    47 Korea University Anam Hospital Seoul Korea, Republic of 02841
    48 Seoul National University Hospital Seoul Korea, Republic of 03080
    49 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    50 Severance Hospital Seoul Korea, Republic of 03722
    51 Seoul National University Hospital Seoul Korea, Republic of 03830
    52 SoonChunHyang University Hospital Seoul Korea, Republic of 04401
    53 Hanyang University Hospital Seoul Korea, Republic of 04763
    54 Konkuk University Medical Center Seoul Korea, Republic of 05030
    55 Asan Medical Center Seoul Korea, Republic of 05505
    56 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 05535
    57 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    58 Samsung Medical Center Seoul Korea, Republic of 06351
    59 Chung-Ang University Hospital Seoul Korea, Republic of 06973
    60 SMG - SNU Boramae Medical Center Seoul Korea, Republic of 07061
    61 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 07985
    62 Inje University Seoul Paik Hospital Seoul Korea, Republic of 100-032
    63 Korea University Guro Hospital Seoul Korea, Republic of 152-703
    64 Eulji General Hospital Seoul Korea, Republic of
    65 Inje University Sanggye Paik Hospital Seoul Korea, Republic of
    66 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Korea, Republic of 41931
    67 The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu-si Korea, Republic of
    68 Ulsan University Hospital Ulsan Korea, Republic of 44033
    69 DongKang Hospital Ulsan Korea, Republic of 44455
    70 Ulsan Hospital Ulsan Korea, Republic of 44686
    71 Yonsei University Wonju Severance Christian Hospital Wonju-si Korea, Republic of 49201
    72 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 50612

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02951364
    Other Study ID Numbers:
    • GS-US-337-1966
    First Posted:
    Nov 1, 2016
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gilead Sciences
    observational
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Sofosbuvir
    Ledipasvir, sofosbuvir drug combination
    Ledipasvir

    Study Results

    No Results Posted as of Nov 29, 2021