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

NCT04189627 | Completed

• 1 other identifier: P20-105
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus (HCV); Chronic Hepatitis C (C); Maviret

Outcome Measures

Primary Outcomes (1)

• Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)

  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.

  At Week 12

Secondary Outcomes (6)

• Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site

  At Week 12

• Number of Participants With Co-morbidities

  At Baseline Visit (Week 0)

• Number of Participants Taking Concomitant Medications

  Up to approximately 28 weeks

• Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose

  Up to approximately 16 weeks

• Number of Participants with Adverse Events

  Up to approximately 28 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

Dagestan State Medical University /ID# 218500

Makhachkala, Dagestan, Respublika, 367000, Russia

Location

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

Kazan', Tatarstan, Respublika, 420140, Russia

Location

South-Ural Medical State University /ID# 218501

Chelyabinsk, 454048, Russia

Location

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

Irkutsk, 664035, Russia

Location

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

Moscow, 115093, Russia

Location

Infectious Clinical Hosp #1 /ID# 218497

Moscow, 125310, Russia

Location

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

Samara, 443029, Russia

Location

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

Yekaterinburg, 620102, Russia

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 6, 2019
• Study Start: February 17, 2020
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

RU (8)