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 (DETI-2)

AbbVie

Status: Completed

Conditions: Hepatitis C Virus (HCV)

Study type: Observational

Funder types: Industry

Identifiers

NCT04189627

P20-105

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No 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

Trial design

99 participants in 1 patient group

Participants Treated with GLE/PIB

Description:

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.