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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 | Clinical Trials | Clareo Health

COMPLETED

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

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)

NCT04189627•AbbVie

View on ClinicalTrials.gov

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

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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

Locations (8)

Dagestan State Medical University /ID# 218500

Makhachkala, Dagestan, Respublika, Russia

A.F.Agafonov Republican Clinical Infectious Hospital /ID# 218498

Kazan', Tatarstan, Respublika, Russia

South-Ural Medical State University /ID# 218501

Chelyabinsk, Russia

Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 222252

Irkutsk, Russia

Children's Clinical Multidisciplinary Center of the Moscow Region /ID# 226590

Moscow, Russia

Infectious Clinical Hosp #1 /ID# 218497

Moscow, Russia

Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 218499

Samara, Russia

Sverdlovsk Regional Center of AIDS Prevention and Control /ID# 222253

Yekaterinburg, Russia

Key Dates

Start Date

February 17, 2020

Primary Completion Date

June 24, 2021

Completion Date

June 24, 2021

Last Updated

June 27, 2022

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus (HCV)

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NCT07388979

HIV - Human Immunodeficiency VirusHBV (Hepatitis B Virus)+6 more

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COMPLETEDPHASE3

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02219490

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)

A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection