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Completed

NCT Number: 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

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.

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dagestan State Medical University /ID# 218500, Makhachkala, Dagestan, Respublika, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: At Week 12

    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.

Secondary outcomes

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

    Time frame: At Week 12

    Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the stie 12 weeks after the last actual dose of GLE/PIB.

  2. Number of Participants With Co-morbidities

    Time frame: At Baseline Visit (Week 0)

    Number and percentage of participants with co-morbidities will be analyzed.

  3. Number of Participants Taking Concomitant Medications

    Time frame: Up to approximately 28 weeks

    Number and percentage of participants taking concomitant medications will be analyzed.

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

    Time frame: Up to approximately 16 weeks

    Percentage of GLE/PIB pills taken out of the number that was prescribed.

  5. Number of Participants with Adverse Events

    Time frame: Up to approximately 28 weeks

    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.

  6. Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU)

    Time frame: Up to approximately 28 weeks

    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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: DETI-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2019
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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