Hepatitis CNCT02562742
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
An observational study of Hepatitis C, run by Gilead Sciences at 45 sites in Japan.
Trial summary
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- SOF and REB
- Type of treatment
- Pill or oral medicine
- How many people
- 554 participants
- Where
- 45 sitesJapan
- Study dates
- 12 Nov 2015to 12 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
Who may be able to join
- Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
- Patients who are prescribed SOF+REB
Who cannot join
- None
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Japan45 sites
Study site
Ageo-shi
Study site
Bunkyō City
Study site
Chuo-shi
Study site
Fujioka-shi
Study site
Fukui-shi
Study site
Fukuoka
Study site
Hakodate-shi
Study site
Handa-shi
Study site
Ichihara-shi
Study site
Inashiki-gun
Study site
Iruma-gun
Study site
Kamogawa-shi
Study site
Karatsu-shi
Study site
Kashiwa-shi
Study site
Katsushika-ku
Study site
Kawagoe-shi
Study site
Kawasaki-shi
Study site
Kitamoto-shi
Study site
Kobe
Study site
Kodaira-shi
Study site
Kōtoku
Study site
Kurume-shi
Study site
Kyoto
Study site
Matsue
Study site
Matsuyama
Study site
Minatoku
Study site
Miyazaki
Study site
Morioka
Study site
Nagoya
Study site
Osaka
Study site
Osakasayama-shi
Study site
Saitama-shi
Study site
Sakaishi
Study site
Sapporo
Study site
Shibuya-ku
Study site
Shimotsuke-shi
Study site
Shinjuku-ku
Study site
Sumida-ku
Study site
Tagawa-shi
Study site
Tondabayashi-shi
Study site
Toyama
Study site
Toyoake-shi
Study site
Utsunomiya
Study site
Yanagawa-shi
Study site
Yokohama
About this study
Official title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
- Conditions
- Hepatitis C
- Being tested
- SOF, REB
- Keywords
- Hepatitis C virus, observational, post-marketing, sofosbuvir, Infection
- Medical subject headings
- Hepatitis C, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
SOF 400 mg tablets administered orally once daily
REBDrug
Also called Rebetol®, Ribavirin
REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
| Study group | Role | What they receive |
|---|---|---|
| SOF+REB | Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site. Receives: Drug: SOF; Drug: REB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reaction (ADR) under real world settings
Measured: Up to 16 weeks
Secondary outcomes (2)
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Measured: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Measured: Approximately 12 weeks after treatment completion or discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start12 Nov 2015
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562742
- Sponsor's protocol ID
- GS-US-334-1879
- Status last verified
- Jul 2017
- First submitted
- 28 Sep 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT02562742
- Acronym / sponsor ID
- GS-US-334-1879
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C virus, observational, post-marketing, sofosbuvir, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 29 Sep 2015 (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.
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF+REB | – | Drug: SOF, Drug: REBAdult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
Key inclusion criteria (2 listed)
- Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
- Patients who are prescribed SOF+REB
Key exclusion criteria (2 listed)
- None
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| SOFAlso: Sovaldi®, GS-7977, PSI-7977SOF 400 mg tablets administered orally once daily | Drug | SOF+REB |
| REBAlso: Rebetol®, RibavirinREB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg) | Drug | SOF+REB |
Primary outcome
Incidence of adverse drug reaction (ADR) under real world settings
Time frame: Up to 16 weeks
2 secondary outcomes
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
Time frame: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Time frame: Approximately 12 weeks after treatment completion or discontinuation
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 1 Aug 2017.
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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
45 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, run by Gilead Sciences at 45 sites in Japan.
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 2 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Japan. 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 drug reaction (ADR) under real world settings (time frame: Up to 16 weeks). 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 1 Aug 2017.