Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04366973
Other study ID # P20-127
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 26, 2020
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest. 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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Followed in an addiction center. - Confirmed positive for HCV ribonucleic acid (RNA). Exclusion Criteria: -None.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277 Antibes
France Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710 Bagneux Ile-de-France
France CSAPA Bagnols sur ceze /ID# 233397 Bagnols Sur Ceze Gard
France Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673 Bayonne
France CEID Bordeaux /ID# 221517 Bordeaux Gironde
France Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695 Bron Rhone
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 de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284 Lille Nord
France Centre Bobillot - Limoges /ID# 221922 Limoges
France Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954 Marseille
France Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671 Metz Moselle
France Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675 Montauban Occitanie
France Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683 Montpellier Herault
France Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700 Montpellier Herault
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 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- Malaussena /ID# 218703 Nice
France Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680 Nimes Gard
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 Csapa Doaur Nevez de Ploermel /Id# 240583 Ploermel Morbihan
France Association Tremplin 17 - Saintes /ID# 218708 Saintes Nouvelle-Aquitaine
France Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678 Strasbourg
France Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701 Valence Drome

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit. Percentage of participants with and without HCV treatment prescribed at end of the inclusion visit. Criteria for treatment choice and reasons for treatment refusal will be described. Inclusion visit (Week 0)
Secondary Health Care Resources and Utilization HCRU in the addiction centers will be described on the basis of declarative questionnaires completed at time of the study implementation (yearly number of people followed, health resources, staffing, formation of center team, capabilities regarding HCV screening, specialized consultations in hepatology, and liver fibrosis tests). Inclusion visit (Week 0)
Secondary Level of HCV infection knowledge The level of knowledge of both patients and providers on HCV infection will be described on the basis of declarative questionnaires. For patients, analysis will be performed in the TP population and according to patient subgroups (with and without HCV treatment). Inclusion visit (Week 0)
Secondary Determinants associated with initiation of HCV treatment Criteria for treatment choice or no treatment uptake assessed by physician, patient, and disease characteristics. Inclusion visit (Week 0)
Secondary Data and disease characteristics from patients with and without HCV treatment Data and disease characteristics from patients with and without HCV treatment. Inclusion visit (Week 0)
Secondary Number of participants with HCV Antibodies (HCV Ab) Number of participants with HCV Antibodies (HCV Ab). Inclusion visit (Week 0)
Secondary Number of participants with HCV RNA Number of participants with HCV RNA. Inclusion visit (Week 0)
Secondary Time from HCV Ab to HCV RNA Time from HCV Ab to HCV RNA. Inclusion visit (Week 0)
Secondary Time from HCV RNA to end of treatment Time from HCV RNA to end of treatment. Approximately 12 months
Secondary Number of participants who completed treatment Number of participants who completed treatment. Approximately 12 months
Secondary Percentage of participants achieving SVR12 SVR12 defined as HCV RNA under the lower limit of quantification (LLOQ) 12 weeks after the last dose of treatment with a sensitive polymerase chain reaction (PCR) test. Approximately 12 months
Secondary Percentage of cured participants willing to share their experience with other substance abuse patients. Percentage of cured participants willing to share their experience with other substance abuse patients at the SVR12 visit and up to 6 months after the SVR12 visit. Approximately 12 months
Secondary Number of participants achieving sustained viral response at 12 weeks (SVR12) Number of participants achieving sustained viral response at 12 weeks (SVR12). Approximately 12 months
Secondary Time to SVR12 Time to SVR12 Approximately 12 months
Secondary Number of people in charge of patient follow-up Number of people in charge of patient follow-up including physicians, nurses, social workers. Approximately 12 months
Secondary Percentage of participants with treatment adherence Defined as the percentage of participants who have taken the target dose according to participant reporting. Approximately 12 months
Secondary Patient Reported Quality of Life Anxiety and depression questionnaires and global assessment using visual analog scale. Approximately 12 months
Secondary Number of participants with addictive behaviors Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires. Approximately 12 months
See also
  Status Clinical Trial Phase
Completed NCT02487199 - Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease Phase 3
Completed NCT03235349 - Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection Phase 3
Completed NCT04577482 - Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
Completed NCT03222583 - A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection Phase 3
Completed NCT02609659 - Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection Phase 3
Completed NCT04352309 - Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis
Completed NCT03069365 - A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment Phase 3
Completed NCT01754974 - Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C Phase 3
Withdrawn NCT01447394 - Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Phase 3
Completed NCT03067129 - A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection Phase 2/Phase 3
Completed NCT03219216 - A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection Phase 3
Completed NCT02517515 - ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection Phase 3
Completed NCT01616524 - Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 Phase 3
Completed NCT02966795 - A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection Phase 3
Completed 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
Completed NCT03341871 - Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Recruiting NCT04214028 - A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
Completed NCT03212521 - Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1 Phase 3
Active, not recruiting NCT04903626 - Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB) Phase 3
Completed NCT03201718 - A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

External Links