A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers
NCT ID: NCT04366973
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
95 participants
OBSERVATIONAL
2020-05-26
2023-12-31
Brief Summary
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Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.
All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.
All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Hepatitis C Virus With or Without Treatment
This study includes 3 populations for analysis:
Target Population (TP): Defined as all participants enrolled in the study regardless of whether treated for HCV or not.
Core Population (CP): Defined as all participants of the TP who have been prescribed glecaprevir/pibrentasvir (G/P) and started treatment.
Safety Population (SP): Defined as all participants who received at least one dose of G/P.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Confirmed positive for HCV ribonucleic acid (RNA).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682
Nice, Alpes-Maritimes, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701
Valence, Drome, France
CSAPA Bagnols sur ceze /ID# 233397
Bagnols-sur-Cèze, Gard, France
Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680
Nîmes, Gard, France
CEID Bordeaux /ID# 221517
Bordeaux, Gironde, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700
Montpellier, Herault, France
Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683
Montpellier, Herault, France
Csapa Doaur Nevez de Ploermel /Id# 240583
Ploërmel, Morbihan, France
Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671
Metz, Moselle, France
Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284
Lille, Nord, France
Association Tremplin 17 - Saintes /ID# 218708
Saintes, Nouvelle-Aquitaine, France
Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675
Montauban, Occitanie, France
Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695
Bron, Rhone, France
Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277
Antibes, , France
Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673
Bayonne, , France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278
Clermont-Ferrand, , France
Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793
Cognac, , France
Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792
Colmar, , France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909
Fontaine-lès-Dijon, , France
Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281
Le Coudray, , France
Centre Bobillot - Limoges /ID# 221922
Limoges, , France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954
Marseille, , France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776
Mulhouse, , France
Clinique Jules Verne /ID# 241666
Nantes, , France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703
Nice, , France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516
Paris, , France
CSAPA CAARUD Aurore EGO /ID# 225050
Paris, , France
CEID Bearn addictions /ID# 221279
Pau, , France
Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678
Strasbourg, , France
Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710
Bagneux, Île-de-France Region, France
Countries
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Related Links
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Related Info
Other Identifiers
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P20-127
Identifier Type: -
Identifier Source: org_study_id
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