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

Hepatitis C Virus (HCV) Clinical Trial

— DETI-2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189627
• Other study ID #: P20-105
• Status: Completed
• Start date: February 17, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: June 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Russian Federation	South-Ural Medical State University /ID# 218501	Chelyabinsk
Russian Federation	Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253	Ekaterinburg
Russian Federation	Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252	Irkutsk
Russian Federation	A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498	Kazan	Tatarstan, Respublika
Russian Federation	Dagestan State Medical University /ID# 218500	Makhachkala	Dagestan, Respublika
Russian Federation	Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590	Moscow
Russian Federation	Infectious Clinical Hosp #1 /ID# 218497	Moscow
Russian Federation	Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499	Samara

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)	Defined as HCV RNA <50 IU/mL or	At Week 12
Secondary	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	At Week 12
Secondary	Number of Participants With Co-morbidities	Number and percentage of participants with co-morbidities will be analyzed.	At Baseline Visit (Week 0)
Secondary	Number of Participants Taking Concomitant Medications	Number and percentage of participants taking concomitant medications will be analyzed.	Up to approximately 28 weeks
Secondary	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.	Up to approximately 16 weeks
Secondary	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.	Up to approximately 28 weeks
Secondary	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).	Up to approximately 28 weeks

External Links

•   clinical study report synopsis