Hepatitis C VirusNCT02907996
Evaluate the Safety and Effectiveness of Sovaldi in Participants 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 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). 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?
- Sofosbuvir
- Type of treatment
- Pill or oral medicine
- How many people
- 2,033 participants
- Where
- 72 sitesSouth Korea
- Study dates
- 9 Sep 2016to 9 Dec 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 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
South Korea72 sites
Hallym University Sacred Heart Hospital
Anyang, 14068
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, 14647
SoonChunHyang University Bucheon Hospital
Bucheon-si, 420-767
Inje University Haeundae Paik Hospital
Busan, 48108
BongSeng Memorial Hospital
Busan, 48775
Dong-A University Hospital
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, 27376
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
DaeJeon ST. Mary's Hospital
Daejeon, 301-723
Chungnam National University Hospital
Daejeon, 35015
Daejeon Eulji Medical Center
Daejeon, 35233
GangNeung Asan Hospital
Gangneung, 25440
Dongguk University Ilsan Hospital
Goyang, 10326
Myongji Hospital
Goyang, 10475
National Health Insurance Cooperation Ilsan Hospital
Goyang-si, 10444
Kumi Cha Hospital
Gumi, 39295
Hanyang University Guri Hospital
Guri-si, 11923
Konkuk University Medical Center
Gwangjin-gu, 05030
Chosun University Hospital
Gwangju, 501-717
Kwangju Christian Hospital
Gwangju, 61661
Dongguk University Gyeongju Hospital
Gyeongju, 38067
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
Catholic Kwandong University International St. Mary's Hospital
Incheon, 22711
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, 52727
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
Seoul National University Hospital
Seoul, 03830
SoonChunHyang University Hospital
Seoul, 04401
Hanyang University Hospital
Seoul, 04763
Asan Medical Center
Seoul, 05505
Kangdong Sacred Heart Hospital
Seoul, 05535
Chung-Ang University Hospital
Seoul, 06973
Boramae Medical Center
Seoul, 07061
Ewha Womans University Mokdong Hospital
Seoul, 07985
Inje University Seoul Paik Hospital
Seoul, 100-032
Severance Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Korea University Guro Hospital
Seoul, 152-703
Inje University Sanggye Paik Hospital
Seoul
Nowon Eulji Medical Center
Seoul
CHA Bundang Medical Center
Sungnam, Gyeonggi-d, 463-712
Ajou University Hospital
Suwon, 16499
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 41931
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
Ulsan University Hospital
Ulsan, 44033
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Pusan National University Yangsan Hospital
Yangsan, 50612
Yongin Severance Hospital
Yŏngin, 17046
About this study
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
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).
- Conditions
- Hepatitis C Virus
- Being tested
- Sofosbuvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called Sovaldi ®
400 mg tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First dose date up to 30 days posttreatment
Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)
Measured: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
Secondary outcomes (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
Measured: First dose date up to 12 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start9 Sep 2016
- Primary completion9 Dec 2021
- Study completion9 Dec 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,033 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
- NCT02907996
- Sponsor's protocol ID
- GS-US-334-1967
- Status last verified
- Dec 2021
- First submitted
- 16 Sep 2016
- Last updated
- 27 Dec 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 27 Dec 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 Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
- ClinicalTrials.gov ID
- NCT02907996
- Acronym / sponsor ID
- GS-US-334-1967
- Conditions
- Hepatitis C Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,033 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 20 Sep 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 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir | – | Drug: SofosbuvirAdult 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 |
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 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.
Key inclusion criteria (3 listed)
- 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 (8 listed)
- 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
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 |
|---|---|---|
| SofosbuvirAlso: Sovaldi ®400 mg tablet administered orally once daily | Drug | Sofosbuvir |
Primary outcome
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
Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)
Time frame: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
1 secondary outcome
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
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 27 Dec 2021.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- 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 3 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 27 Dec 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?
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). 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 27 Dec 2021.