Hepatitis C Virus (HCV)CHOICENCT04577482
Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 10 sites in Russia.
Trial summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV)
- How many people
- 42 participants
- Where
- 10 sitesRussia
- Study dates
- 7 Oct 2020to 3 Sep 2022
- 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: Participants with hepatitis C virus (HCV) infection of genotype 1 prescribed with glecaprevir/pibrentasvir in accordance with local clinical practice and label.
Who may be able to join
- Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
- Participants can enroll up to 4 weeks after starting treatment
Who cannot join
- Participating or intending to participate in a concurrent interventional therapeutic trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
South Ural State Medical University /ID# 226555
Chelyabinsk, 454048
LLC Center of Targeted Therapy /ID# 239529
Domodedovo, 142007
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
Irkutsk, 664035
Specialized Clinical Infectious Diseases Hospital /ID# 229814
Krasnodar, 350000
Infectious Clinical Hosp #1 /ID# 225063
Moscow, 125310
Infectious Clinical Hospita l#2 /ID# 243217
Nizhny Novgorod, 603022
S. P. Botkin City Hospital /ID# 229510
Oryol, 302038
Saint-Petersburg AIDS Center /ID# 239357
Saint Petersburg, 190103
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
Samara, 443029
Stavropol State Medical University /ID# 243216
Stavropol, 355017
About this study
Official title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Read more
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C Infection, Glecaprevir/pibrentasvir, GLE/PIB, CHOICE, Chronic Hepatitis C Genotype 1
- Medical subject headings
- Hepatitis C
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 |
|---|---|---|
| Participants treated with Glecaprevir/Pibrentasvir | Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
Measured: Week 12 after the end of treatment
Secondary outcomes (6)
Percentage of Participants Achieving SVR12
SVR12 is defined as HCV RNA < LLoQ/D 12 weeks after the last actual dose of GLE/PIB with a sensitive polymerase chain reaction (PCR) available in the clinical site in the settings of the Russian Federation in subgroups of interest.
Measured: Week 12 after the end of treatment
Number of Participants With Co-morbidities and Taking Concomitant Medication
Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated.
Measured: Up to Week 12 after the end of treatment
Health Care Resource Utilization (HCRU)
HCRU will be 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 as recorded overall and by subpopulations of interest.
Measured: Up to Week 12 after the end of treatment
Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose
Number of pills taken out of the number that should have been taken will be calculated.
Measured: Up to Week 12 after the end of treatment
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug overall and in subgroups of interest. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Up to Week 12 after the end of treatment
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values
Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest.
Measured: Up to Week 12 after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Oct 2020
- Primary completion3 Sep 2022
- Study completion3 Sep 2022
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
- 42 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
- NCT04577482
- Sponsor's protocol ID
- P20-397
- Acronym
- CHOICE
- Status last verified
- Aug 2023
- First submitted
- 30 Sep 2020
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. 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/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)
- ClinicalTrials.gov ID
- NCT04577482
- Acronym / sponsor ID
- CHOICE / P20-397
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C Infection, Glecaprevir/pibrentasvir, GLE/PIB, CHOICE, Chronic Hepatitis C Genotype 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 8 Oct 2020 (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.
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Glecaprevir/Pibrentasvir | – | –Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with hepatitis C virus (HCV) infection of genotype 1 prescribed with glecaprevir/pibrentasvir in accordance with local clinical practice and label.
Key inclusion criteria (2 listed)
- Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
- Participants can enroll up to 4 weeks after starting treatment
Key exclusion criteria (1 listed)
- Participating or intending to participate in a concurrent interventional therapeutic trial.
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 (SVR) at Week 12 (SVR12)
Time frame: Week 12 after the end of treatment
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
6 secondary outcomes
Percentage of Participants Achieving SVR12
Time frame: Week 12 after the end of treatment
Number of Participants With Co-morbidities and Taking Concomitant Medication
Time frame: Up to Week 12 after the end of treatment
Health Care Resource Utilization (HCRU)
Time frame: Up to Week 12 after the end of treatment
Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose
Time frame: Up to Week 12 after the end of treatment
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 12 after the end of treatment
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values
Time frame: Up to Week 12 after the end of treatment
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 14 Aug 2023.
- 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
10 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 (HCV), run by AbbVie at 10 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 2 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 (SVR) at Week 12 (SVR12) (time frame: Week 12 after the end of treatment). 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 14 Aug 2023.