Clinical trial NCT04189627: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C Virus (HCV)
Chronic Hepatitis C (C)
Maviret
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

None

Primary outcomes:
measure: Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site
timeFrame: At Week 12
measure: Number of Participants With Co-morbidities
timeFrame: At Baseline Visit (Week 0)
measure: Number of Participants Taking Concomitant Medications
timeFrame: Up to approximately 28 weeks
measure: Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose
timeFrame: Up to approximately 16 weeks
measure: Number of Participants with Adverse Events
timeFrame: Up to approximately 28 weeks
measure: Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU)
timeFrame: Up to approximately 28 weeks
Other outcomes:
Locations:
city: Makhachkala
country: Russian Federation
facility: Dagestan State Medical University /ID# 218500
state: Dagestan, Respublika
city: Kazan
country: Russian Federation
facility: A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498
state: Tatarstan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: South-Ural Medical State University /ID# 218501
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252
city: Moscow
country: Russian Federation
facility: Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hosp #1 /ID# 218497
city: Samara
country: Russian Federation
facility: Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: