Chronic Hepatitis C (CHC)EVERESTNCT03868163
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
An observational study of Chronic Hepatitis C (CHC), run by AbbVie at 9 sites in Russia.
Trial summary
This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C (CHC)
- How many people
- 161 participants
- Where
- 9 sitesRussia
- Study dates
- 28 Feb 2019to 4 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CHC in a real world clinical practice setting.
Who may be able to join
- Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
- May be enrolled up to 4 weeks after treatment initiation.
- Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
Who cannot join
- None.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
South Ural State Medical univ /ID# 212020
Chelyabinsk, 454052
A. F. Agafonov Republican Clin /ID# 212381
Kazan', Tatarstan, Respublika, 420140
Clinical Inf. Dis Hospital 1 /ID# 217033
Novosibirsk, 630099
SIH Orlovskiy region city hospital named after S.P. Botkin /ID# 212383
Oryol, 302038
Perm Regional Center of Cepato /ID# 213992
Perm, 614000
Saint-Petersburg AIDS Center /ID# 212380
Saint Petersburg, 190103
LLC Medical Company Hepatolog /ID# 212384
Samara, Samara Oblast, 443063
Samara State Medical Universit /ID# 217029
Samara, 443099
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 217035
Stavropol, Stavropol Kray, 355035
About this study
Official title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.
- Conditions
- Chronic Hepatitis C (CHC)
- Keywords
- Chronic Hepatitis C, Hepatitis C, Hepatitis, glecaprevir, pibrentasvir, real world setting, Observational Study
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Hepatitis
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 |
|---|---|---|
| Glecaprevir plus Pibrentasvir | Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
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 less than the lower limit of quantification/detection (<LLOQ/D) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir (GLE/PIB).with a sensitive polymerase chain reaction [PCR] test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Secondary outcomes (10)
Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by CHC Genotype
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB.with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Cirrhosis Status
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay
Measured: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Previous Treatment Experience
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Patients Who Use Drugs
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Percentage of Elderly Participants Achieving SVR12
SVR12 defined as the HCV RNA level <LLOQ/D 12 weeks after the last dose of GLE/PIB with a sensitive PCR test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
Measured: Up to approximately 28 weeks
Percentage of Patients with Commodities
Percentage of Patients with Commodities from the decision to initiate treatment.
Measured: Up to approximately 16 weeks
Percentage of Participants Taking Concomitant Medications
The percentage of participants taking concomitant medications from the decision to initiate treatment through up to 12 weeks after the last dose of GLE/PBR
Measured: Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken
Percentage of GLE/PIB dose taken by patient report in relation to the prescribed target dose (that is, the number of pills taken out of the number that should have been taken).
Measured: Up to approximately 16 weeks
Number of Health Care Resource Utilization (HCRU)
Health Care Resource Utilization (HCRU) for a patient will be the total number of visits/touchpoints (face to face or phone call) with a Health Care Provider (HCP) or designee in relation to their HCV infection during the study.
Measured: Up to approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start28 Feb 2019
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C (CHC)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
- 161 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
- NCT03868163
- Sponsor's protocol ID
- P19-454
- Acronym
- EVEREST
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2019
- Last updated
- 30 Aug 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
- ClinicalTrials.gov ID
- NCT03868163
- Acronym / sponsor ID
- EVEREST / P19-454
- Conditions
- Chronic Hepatitis C (CHC)
- Keywords
- Chronic Hepatitis C, Hepatitis C, Hepatitis, glecaprevir, pibrentasvir, real world setting, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 8 Mar 2019 (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 study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glecaprevir plus Pibrentasvir | – | –Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CHC in a real world clinical practice setting.
Key inclusion criteria (4 listed)
- Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
- May be enrolled up to 4 weeks after treatment initiation.
- Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
Key exclusion criteria (1 listed)
- None.
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: Up to approximately 28 weeks
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification/detection (<LLOQ/D) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir (GLE/PIB).with a sensitive polymerase chain reaction [PCR] test with an LLoQ/D of <50 IU/mL or as described in a validated assay.
10 secondary outcomes
Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status
Time frame: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by CHC Genotype
Time frame: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Cirrhosis Status
Time frame: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Previous Treatment Experience
Time frame: Up to approximately 28 weeks
Percentage of Participants Achieving SVR12 by Patients Who Use Drugs
Time frame: Up to approximately 28 weeks
Percentage of Elderly Participants Achieving SVR12
Time frame: Up to approximately 28 weeks
Percentage of Patients with Commodities
Time frame: Up to approximately 16 weeks
Percentage of Participants Taking Concomitant Medications
Time frame: Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken
Time frame: Up to approximately 16 weeks
Number of Health Care Resource Utilization (HCRU)
Time frame: Up to approximately 28 weeks
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 30 Aug 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Hepatitis C (CHC)
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C (CHC), run by AbbVie at 9 sites in Russia.
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 4 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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: Up to approximately 28 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 30 Aug 2021.