Hepatitis C VirusNCT02951364
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
An observational study of Hepatitis C Virus, run by Gilead Sciences at 72 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- LDV/SOF
- Type of treatment
- Pill or oral medicine
- How many people
- 1,081 participants
- Where
- 72 sitesSouth Korea
- Study dates
- 5 Dec 2016to 11 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult Korean individuals and pediatric Korean individuals aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
South Korea72 sites
Hallym University Sacred Heart Hospital
Anyang-si, 14068
SoonChunHyang University Bucheon Hospital
Bucheon-si, 14584
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, 14647
Bumin Hospital Haeundae
Busan, 48094
Inje University Haeundae Paik Hospital
Busan, 48108
Good Gang-An Hospital
Busan, 48265
Dong-A University Medical Center
Busan, 49201
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Inje University Busan Paik Hospital
Busan, 614-735
Busan St. Mary's Hospital
Busan
Busan Veterans Hospital
Busan
Maryknoll Medical Center
Busan
Changwon Fatima Hospital
Changwon, 51394
Dankook University Hospital
Cheonan, 31116
SoonChunHyang University Cheonan Hospital
Cheonan, 31151
Hallym University ChunCheon Sacred Heart Hospital
Chuncheon, 24253
Konkuk University Chungju Hospital
Chungju
Keimyung University Dongsan Medical Center
Daegu, 41931
Yeungnam University Medical Center
Daegu, 42415
Daegu Catholic University Medical Center
Daegu, 42472
Kyungpook National University Hospital
Daegu, 700-721
Kyungpook national university medical center Chil-Gok
Daegu, 700-721
Chungnam National University Hospital
Daejeon, 35015
Konyang University Hospital
Daejeon, 35365
GangNeung Asan Hospital
Gangneung-si
Dongguk University Ilsan Hospital
Goyang, 10326
Myongji Hospital
Goyang, 10475
National Health Insurance Corporation Ilsan Hospital
Goyang-si, 10444
Kumi Cha Hospital
Gumi, 39295
Chosun University Hospital
Gwangju, 501-717
Kwangju Christian Hospital
Gwangju
Hanyang University Guri Hospital
Gyeonggi-do, 11923
Dongguk University Gyeongju Hospital
Gyeongju
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
Chonnam National University Hwasun Hospital
Hwasun, 58128
WonKwang University Hospital
Iksan, 54538
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431
Inha University Hospital
Incheon, 22332
Gachon University Gil Medical Center
Incheon, 405-760
Cheju Halla General Hospital
Jeju City, 63127
Presbyterian Medical Center
Jeonju, 54987
Chonbuk National University Hospital
Jeonju
Gyeongsang National University Hospital
Jinju, 660-702
CHA Bundang Medical Center
Seongnam-si, Gyeonggido, 13496
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Severance Hospital
Seoul, 03722
Seoul National University Hospital
Seoul, 03830
SoonChunHyang University Hospital
Seoul, 04401
Hanyang University Hospital
Seoul, 04763
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center
Seoul, 05505
Kangdong Sacred Heart Hospital
Seoul, 05535
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Chung-Ang University Hospital
Seoul, 06973
SMG - SNU Boramae Medical Center
Seoul, 07061
Ewha Womans University Mokdong Hospital
Seoul, 07985
Inje University Seoul Paik Hospital
Seoul, 100-032
Korea University Guro Hospital
Seoul, 152-703
Eulji General Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 41931
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si
Ulsan University Hospital
Ulsan, 44033
DongKang Hospital
Ulsan, 44455
Ulsan Hospital
Ulsan, 44686
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 49201
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
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
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.
- Conditions
- Hepatitis C Virus
- Being tested
- LDV/SOF
- Keywords
- observational
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDV/SOFDrug
Also called Harvoni®, GS-5885/GS-7977
90/400 mg tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: LDV/SOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
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.
Measured: Up to 30 days following treatment
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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.
Measured: Posttreatment Week 12
Secondary outcomes (1)
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.
Measured: Up to Posttreatment Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start5 Dec 2016
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951364
- Sponsor's protocol ID
- GS-US-337-1966
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2016
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02951364
- Acronym / sponsor ID
- GS-US-337-1966
- Conditions
- Hepatitis C Virus
- Keywords
- observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDV/SOF | – | Drug: LDV/SOFAdult 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult Korean individuals and pediatric Korean individuals aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
Key inclusion criteria (2 listed)
- 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 (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDV/SOFAlso: Harvoni®, GS-5885/GS-797790/400 mg tablet administered orally once daily | Drug | LDV/SOF |
Primary outcome
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
Time frame: Up to Posttreatment Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by Gilead Sciences at 72 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) (time frame: Up to 30 days following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.