Hepatitis C Virus (HCV)EASYNCT04352309
Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 6 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) and liver cancer leaving trial participants with 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
- 99 participants
- Where
- 6 sitesRussia
- Study dates
- 29 May 2020to 11 Jun 2021
- 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: Treatment-naive Pediatric (12 years and older) and adult participants with confirmed Chronic Hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6 with compensated cirrhosis, being treated with oral Glecaprevir/Pibrentasvir (GLE/PIB) according to standard of care, international guidelines and in line with the current local label.
Who may be able to join
- Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
- Participants may be enrolled up to 4 weeks after treatment initiation.
Who cannot join
- Participating or intending to participate in a concurrent interventional therapeutic trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
South Ural State Medical University /ID# 225501
Chelyabinsk, 454052
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499
Irkutsk, 664035
S. P. Botkin City Hospital /ID# 225500
Oryol, 302038
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582
Samara, 443029
Stavropol State Medical University /ID# 226589
Stavropol, 355017
Medical center Academy /ID# 226587
Ulyanovsk, 432063
About this study
Official title: REAl World Evidence Of The Effectiveness And Clinical Practice Use Of Glecaprevir/Pibrentasvir For 8 Weeks Treatment In Patients With Chronic HepatitiS C GenotYpes 1 to 6 And Liver Cirrhosis In Russian Federation (EASY)
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) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.
GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.
Read more
Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.
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
- HCV, Hepatitis C Virus, Hepatitis C, Liver Cirrhosis, GLE/PIB
- Medical subject headings
- Hepatitis C, Liver Cirrhosis
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 (GLE/PIB) | Participants will receive GLE/PIB over 8 weeks of therapy as prescribed by their physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)
SVR12 is defined as Hepatitis C Virus (HCV) RNA < 50 IU/ml or < lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,>=70 days) after the last actual dose.
Measured: At Week 20
Secondary outcomes (7)
Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest
SVR12 is defined as HCV RNA < lower limit of quantification/detection (LLoQ/D) 12 weeks (i.e., >=70 days) 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: At Week 20
Number Of Participants With Co-morbidities
Participants who have other existing medical conditions.
Measured: At Week 20
Number Of Participants Taking Concomitant Medication
Participants who take other medications along with Glecaprevir/Pibrentasvir (GLE/PIB).
Measured: At Week 20
Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose
Percentage of GLE/PIB 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).
Measured: At Week 20
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. 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: Baseline (Week 0) To 30 days post last dose
Percentage of Participants With Shifts in Clinical Laboratory Values
Percentage of participants with clinically significant change in laboratory parameters of interest (hematology, biochemistry, virology, coagulation, and urinalysis), post-baseline during treatment, will be summarized.
Measured: Baseline (Week 0) to Week 20
Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest
HCRU for a participant will be the total number of visits/touchpoints (face to face or phone call) with a Health Care Professional (HCP) or designee in relation to their Hepatitic C Virus (HCV) infection during the study.
Measured: At Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start29 May 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
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
- 99 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
- NCT04352309
- Sponsor's protocol ID
- P20-276
- Acronym
- EASY
- Status last verified
- Jun 2022
- First submitted
- 16 Apr 2020
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. 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 For 8 Weeks Treatment In Patients With Chronic HepatitiS C GenotYpes 1 to 6 And Liver Cirrhosis In Russian Federation (EASY)
- ClinicalTrials.gov ID
- NCT04352309
- Acronym / sponsor ID
- EASY / P20-276
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- HCV, Hepatitis C Virus, Hepatitis C, Liver Cirrhosis, GLE/PIB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 20 Apr 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) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.
GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.
Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.
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 (GLE/PIB) | – | –Participants will receive GLE/PIB over 8 weeks of therapy as prescribed by their physicians. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Treatment-naive Pediatric (12 years and older) and adult participants with confirmed Chronic Hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6 with compensated cirrhosis, being treated with oral Glecaprevir/Pibrentasvir (GLE/PIB) according to standard of care, international guidelines and in line with the current local label.
Key inclusion criteria (2 listed)
- Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
- Participants may be enrolled up to 4 weeks after treatment initiation.
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 Virologic Response At 12 Weeks (SVR12)
Time frame: At Week 20
SVR12 is defined as Hepatitis C Virus (HCV) RNA < 50 IU/ml or < lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,>=70 days) after the last actual dose.
7 secondary outcomes
Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest
Time frame: At Week 20
Number Of Participants With Co-morbidities
Time frame: At Week 20
Number Of Participants Taking Concomitant Medication
Time frame: At Week 20
Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose
Time frame: At Week 20
Number of Participants With Adverse Events
Time frame: Baseline (Week 0) To 30 days post last dose
Percentage of Participants With Shifts in Clinical Laboratory Values
Time frame: Baseline (Week 0) to Week 20
Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest
Time frame: At Week 20
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 9 Jun 2022.
- 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
6 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 6 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Virologic Response At 12 Weeks (SVR12) (time frame: At Week 20). 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 9 Jun 2022.