A prospective open label study to evaluate treatment of chronic HCV infection with glecaprevir/pibrentasvir in PWID attending a needle exchange program

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002008-28-SE

Enrollment

Registered

2017-11-17

Start date

2017-12-21

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Maviret 100 mg/40 mg filmdragerade tabletter glekaprevir/pibrentasvir Maviret 100 mg/40 mg film-coated tablets Product Name: Maviret 100 mg/40 mg tablets Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Registered in the Malmö Needle Exchange Program. 2.Recent injection drug use (within the last 6 months) 3.Written informed consent for participation in the study 4.Chronic HCV infection (as defined above) 5.Female participants must be either postmenopausal, or permanently surgically sterile or, for women of childbearing potential, practicing at least one protocol specified method of birth control (Appendix B) starting at study day 1 through at least 30 days after the last dose of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Female subjects who are pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. 2.Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 3.Screening laboratory analyses showing any of the following abnormal laboratory results: •ALT and/orAST > 10 x ULN •Platelets 8.5% at the Screening Visit. ?Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years. ?Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the rate of sustained virological response at 12 weeks (SVR12) after completion of HCV treatment with the combination of glecaprevir/pibrentasvir in eligible patients attending a needle exchange program. SVR12 is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication. ;Secondary Objective: The secondary objectives are to investigate the: i) Number of re-infections/relapses after 12, 24, 36, 48 and 60 months ii) Completion rate iii) Adherence to treatment iv) Virological resistance pattern in failures and at follow-up v) Effects on health related quality of life (HRQoL) and risk behaviour in active injectors ;Primary end point(s): Sustained virological response at 12 weeks after completion of therapy (SVR 12).;Timepoint(s) of evaluation of this end point: 12 weeks after completion of therapy is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication.	—

Measure

Time frame

Main Objective: To determine the rate of sustained virological response at 12 weeks (SVR12) after completion of HCV treatment with the combination of glecaprevir/pibrentasvir in eligible patients attending a needle exchange program. SVR12 is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication. ;Secondary Objective: The secondary objectives are to investigate the: i) Number of re-infections/relapses after 12, 24, 36, 48 and 60 months ii) Completion rate iii) Adherence to treatment iv) Virological resistance pattern in failures and at follow-up v) Effects on health related quality of life (HRQoL) and risk behaviour in active injectors ;Primary end point(s): Sustained virological response at 12 weeks after completion of therapy (SVR 12).;Timepoint(s) of evaluation of this end point: 12 weeks after completion of therapy is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication.

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Secondary

Measure	Time frame
Secondary end point(s): Completion which is defined as having received study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen. ;Timepoint(s) of evaluation of this end point: Study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen.	—

Measure

Time frame

Secondary end point(s): Completion which is defined as having received study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen. ;Timepoint(s) of evaluation of this end point: Study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen.

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Countries

Sweden

Contacts

Public ContactAnna Jerkeman

Region Skane

anna.jerkeman@med.lu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026