Hepatitis C Virus (HCV)DETI-2NCT04189627
A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
An observational study of Hepatitis C Virus (HCV), run by AbbVie at 8 sites in Russia.
Trial summary
The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hepatitis C Virus (HCV)
- Type of treatment
- Pill or oral medicine
- How many people
- 99 participants
- Where
- 8 sitesRussia
- Study dates
- 17 Feb 2020to 24 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescent participants 12 to <18 years of age with chronic hepatitis C (CHC) being treated with glecaprevir/pibrentasvir (GLE/PIB) in clinical practice in Russian Federation.
Who may be able to join
- Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
- Treatment naive or treatment experienced participants
- Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
- Participant and his/her legal representative voluntarily signs and dates an informed consent form
- Must not be participating or intending to participant in a concurrent interventional therapeutic trial
Who cannot join
- None
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
South-Ural Medical State University /ID# 218501
Chelyabinsk, 454048
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252
Irkutsk, 664035
A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498
Kazan', Tatarstan, Respublika, 420140
Dagestan State Medical University /ID# 218500
Makhachkala, Dagestan, Respublika, 367000
Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590
Moscow, 115093
Infectious Clinical Hosp #1 /ID# 218497
Moscow, 125310
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499
Samara, 443029
Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253
Yekaterinburg, 620102
About this study
Official title: Real World EviDEnce of the EffecTIveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)
The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C (C), Maviret
- 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 |
|---|---|---|
| Participants Treated with GLE/PIB | Participants treated with all oral glecaprevir/pibrentasvir (GLE/PIB) and the decision to treat with GLE/PIB is made before the decision to offer an opportunity to join this study. Prescription of the treatment regimen is at the discretion of the physician and in accordance with local clinical practice and label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)
Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the site 12 weeks after the last actual dose of GLE/PIB.
Measured: At Week 12
Secondary outcomes (6)
Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site
Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the stie 12 weeks after the last actual dose of GLE/PIB.
Measured: At Week 12
Number of Participants With Co-morbidities
Number and percentage of participants with co-morbidities will be analyzed.
Measured: At Baseline Visit (Week 0)
Number of Participants Taking Concomitant Medications
Number and percentage of participants taking concomitant medications will be analyzed.
Measured: Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose
Percentage of GLE/PIB pills taken out of the number that was prescribed.
Measured: Up to approximately 16 weeks
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product 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 as either probably related, possibly related, probably not related or not related. 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Measured: Up to approximately 28 weeks
Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU)
Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call ) with a health care provider or designee in relation to their HCV infection during the study as recorded on an electronic case report form (eCRF).
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 posted6 Dec 2019
- Study start17 Feb 2020
- Primary completion24 Jun 2021
- Study completion24 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
- NCT04189627
- Sponsor's protocol ID
- P20-105
- Acronym
- DETI-2
- Status last verified
- Jun 2022
- First submitted
- 5 Dec 2019
- Last updated
- 27 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 27 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 in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)
- ClinicalTrials.gov ID
- NCT04189627
- Acronym / sponsor ID
- DETI-2 / P20-105
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Chronic Hepatitis C (C), Maviret
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 6 Dec 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.
The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Treated with GLE/PIB | – | –Participants treated with all oral glecaprevir/pibrentasvir (GLE/PIB) and the decision to treat with GLE/PIB is made before the decision to offer an opportunity to join this study. Prescription of the treatment regimen is at the discretion of the physician and in accordance with local clinical practice and label. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescent participants 12 to <18 years of age with chronic hepatitis C (CHC) being treated with glecaprevir/pibrentasvir (GLE/PIB) in clinical practice in Russian Federation.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
- Treatment naive or treatment experienced participants
- Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
- Participant and his/her legal representative voluntarily signs and dates an informed consent form
- Must not be participating or intending to participant 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
Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)
Time frame: At Week 12
Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the site 12 weeks after the last actual dose of GLE/PIB.
6 secondary outcomes
Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site
Time frame: At Week 12
Number of Participants With Co-morbidities
Time frame: At Baseline Visit (Week 0)
Number of Participants Taking Concomitant Medications
Time frame: Up to approximately 28 weeks
Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose
Time frame: Up to approximately 16 weeks
Number of Participants with Adverse Events
Time frame: Up to approximately 28 weeks
Average Number of Visits/Touch Points as Part 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 27 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
8 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 8 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 5 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 27 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 8 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?
Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) (time frame: At Week 12). 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 2022.