Hepatitis C Virus InfectionNCT02537379
Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
An observational study of Hepatitis C Virus Infection, run by Gilead Sciences at 45 sites in Japan.
Trial summary
This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) 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 Virus Infection
- What is being tested?
- SOF and COPE
- Type of treatment
- Pill or oral medicine
- How many people
- 552 participants
- Where
- 45 sitesJapan
- Study dates
- 15 Sep 2015to 5 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+COPE 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+COPE
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
Amagasaki-shi
Study site
Asahi-shi
Study site
Asahikawa-shi
Study site
Beppu-shi
Study site
Chichibu-shi
Study site
Fujioka-shi
Study site
Fukui-shi
Study site
Hamamatsu
Study site
Iizuka-shi
Study site
Inzai-shi
Study site
Ishinomaki-shi
Study site
Iwaki
Study site
Izunokuni-shi
Study site
Kahoku-gun
Study site
Kanazawa
Study site
Kirishima-shi
Study site
Kisarazu-shi
Study site
Kitamoto-shi
Study site
Kobe
Study site
Koshigaya-shi
Study site
Kure-shi
Study site
Moriguchi-shi
Study site
Nagakute-shi
Study site
Nagaoka-shi
Study site
Nagasaki
Study site
Nagoya
Study site
Nakagami-gun
Study site
Nanto-shi
Study site
Nishinomiya-shi
Study site
Ofukeshi
Study site
Okayama
Study site
Ome-shi
Study site
Osaka
Study site
Ōta-ku
Study site
Sapporo
Study site
Sasebo-Shi
Study site
Sendai
Study site
Shinagawa-ku
Study site
Shinjuku-ku
Study site
Tokorozawa-shi
Study site
Tokushima
Study site
Wakayama
Study site
Yachiyo-shi
Study site
Yokohama
Study site
Yufu-shi
About this study
Official title: A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) 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 Virus Infection
- Being tested
- SOF, COPE
- Keywords
- Hepatitis C virus, observational, post-marketing, 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.
SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
SOF 400 mg tablets administered orally once daily
COPEDrug
Also called Copegus®, Ribavirin
COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® 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+COPE | Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site. Receives: Drug: SOF; Drug: COPE |
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 posted1 Sep 2015 (estimated)
- Study start15 Sep 2015
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537379
- Sponsor's protocol ID
- GS-US-334-1444 / COPE1501
- Status last verified
- Jun 2017
- First submitted
- 28 Aug 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 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 Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT02537379
- Acronym / sponsor ID
- GS-US-334-1444 / COPE1501
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Hepatitis C virus, observational, post-marketing, sofosbuvir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 1 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 post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) 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+COPE | – | Drug: SOF, Drug: COPEAdult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE 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+COPE 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+COPE
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+COPE |
| COPEAlso: Copegus®, RibavirinCOPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg) | Drug | SOF+COPE |
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 27 Jun 2017.
Related trials for Hepatitis C Virus Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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 Virus Infection, 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 27 Jun 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 27 Jun 2017.