DETI-2: 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
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) [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.
Secondary Outcome Measures
- Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site [At Week 12]
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.
- Number of Participants With Co-morbidities [At Baseline Visit (Week 0)]
Number and percentage of participants with co-morbidities will be analyzed.
- Number of Participants Taking Concomitant Medications [Up to approximately 28 weeks]
Number and percentage of participants taking concomitant medications will be analyzed.
- Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose [Up to approximately 16 weeks]
Percentage of GLE/PIB pills taken out of the number that was prescribed.
- Number of Participants with Adverse Events [Up to approximately 28 weeks]
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.
- Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU) [Up to approximately 28 weeks]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
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Treatment naive or treatment experienced participants
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Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
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Participant and his/her legal representative voluntarily signs and dates an informed consent form
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Must not be participating or intending to participant in a concurrent interventional therapeutic trial
Exclusion Criteria:
None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dagestan State Medical University /ID# 218500 | Makhachkala | Dagestan, Respublika | Russian Federation | 367000 |
| 2 | A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498 | Kazan | Tatarstan, Respublika | Russian Federation | 420140 |
| 3 | South-Ural Medical State University /ID# 218501 | Chelyabinsk | Russian Federation | 454048 | |
| 4 | Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253 | Ekaterinburg | Russian Federation | 620102 | |
| 5 | Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252 | Irkutsk | Russian Federation | 664035 | |
| 6 | Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590 | Moscow | Russian Federation | 115093 | |
| 7 | Infectious Clinical Hosp #1 /ID# 218497 | Moscow | Russian Federation | 125310 | |
| 8 | Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499 | Samara | Russian Federation | 443029 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P20-105