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NCT Number: NCT03303599

Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931, Klagenfurt, Carinthia, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
  • Participants may be enrolled up to 4 weeks after treatment initiation
  • Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion criteria

None.

Treatment and study plan

Primary outcomes

  1. Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)

    Time frame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir

    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir

Secondary outcomes

  1. Percentage of Participants Taking Concomitant Medications

    Time frame: Up to approximately 28 weeks

    The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.

  2. Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed

    Time frame: Up to approximately 16 weeks

    The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).

  3. Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Up to 16 weeks

    Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease [MDRD] equation).

  4. Number of Healthcare 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 an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.

  5. Percentage of Participants Using Each Treatment Regimen

    Time frame: Up to 16 weeks

    Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)

  6. Percentage of Participants with Co-morbidities

    Time frame: Baseline (Day 1)

    The percentage of participants with co-morbidities at baseline.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2017
Registry last updated
May 19, 2021

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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