Hepatitis C Virus (HCV)NCT03341871
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 1 site in Japan.
Trial summary
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Hepatitis C Virus (HCV)
- How many people
- 1,095 participants
- Where
- 1 siteJapan
- Study dates
- 27 Dec 2017to 15 Sep 2020
- 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.
Who may be able to join
- Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
Who cannot join
- Patients previously treated with glecaprevir plus pibrentasvir.
Trial locations and contacts
1 site in 1 country.
About this study
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- chronic hepatitis C virus (HCV), Genotype, glecaprevir, pibrentasvir, sustained virologic response, chronic hepatitis C virus genotype 1, chronic hepatitis C virus genotype 2, chronic hepatitis C virus genotype 3, chronic hepatitis C virus genotype 4, chronic hepatitis C virus genotype 5, chronic hepatitis C virus genotype 6
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCV Genotypes 1, 2, 3, 4, 5, or 6 participants | Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Measured: 12 weeks after last dose of drug
Secondary outcomes (5)
Percentage of Participants with Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA >= LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: Up to 24 weeks after last dose of drug
Percentage of Participants with On-treatment Virologic Failure
On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.
Measured: Up to 12 weeks after first dose
Percentage of Participants Achieving SVR4
SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Measured: 4 weeks after last dose
Percentage of Participants Achieving SVR8
SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Measured: 8 weeks after last dose of drug
Percentage of Participants Achieving SVR24
SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Measured: 24 weeks after last dose of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start27 Dec 2017
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341871
- Sponsor's protocol ID
- P16-570
- Status last verified
- Sep 2021
- First submitted
- 9 Nov 2017
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
- ClinicalTrials.gov ID
- NCT03341871
- Acronym / sponsor ID
- P16-570
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- chronic hepatitis C virus (HCV), Genotype, glecaprevir, pibrentasvir, sustained virologic response, chronic hepatitis C virus genotype 1, chronic hepatitis C virus genotype 2, chronic hepatitis C virus genotype 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- 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 multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV Genotypes 1, 2, 3, 4, 5, or 6 participants | – | –Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.
Key inclusion criteria (1 listed)
- Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
Key exclusion criteria (1 listed)
- Patients previously treated with glecaprevir plus pibrentasvir.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after last dose of drug
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.
5 secondary outcomes
Percentage of Participants with Post-treatment Relapse
Time frame: Up to 24 weeks after last dose of drug
Percentage of Participants with On-treatment Virologic Failure
Time frame: Up to 12 weeks after first dose
Percentage of Participants Achieving SVR4
Time frame: 4 weeks after last dose
Percentage of Participants Achieving SVR8
Time frame: 8 weeks after last dose of drug
Percentage of Participants Achieving SVR24
Time frame: 24 weeks after last dose of drug
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 20 Sep 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
1 site 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 (HCV), run by AbbVie at 1 site 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 1 inclusion and 1 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after last dose of drug). 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 20 Sep 2021.