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Hepatitis C Virus (HCV)NeoVieNCT04366973

A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers

An observational study of Hepatitis C Virus (HCV), run by AbbVie at 30 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
How many people
95 participants
Where
30 sitesFrance
Study dates
26 May 2020to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants treated with glecaprevir/pibrentasvir for confirmed positive Hepatitis C Virus.

Who may be able to join

  • Followed in an addiction center.
  • Confirmed positive for HCV ribonucleic acid (RNA).

Who cannot join

  • -None.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277

    Antibes, 06600

  • Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710

    Bagneux, Île-de-France Region, 92220

  • CSAPA Bagnols sur ceze /ID# 233397

    Bagnols-sur-Cèze, Gard, 30200

  • Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673

    Bayonne, 64109

  • CEID Bordeaux /ID# 221517

    Bordeaux, Gironde, 33000

  • Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695

    Bron, Rhone, 69500

  • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278

    Clermont-Ferrand, 63000

  • Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793

    Cognac, 16010

  • Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792

    Colmar, 68000

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909

    Fontaine-lès-Dijon, 21121

  • Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281

    Le Coudray, 28630

  • Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284

    Lille, Nord, 59800

  • Centre Bobillot - Limoges /ID# 221922

    Limoges, 87000

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954

    Marseille, 13001

  • Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671

    Metz, Moselle, 57000

  • Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675

    Montauban, Occitanie, 82000

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700

    Montpellier, Herault, 34000

  • Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683

    Montpellier, Herault, 34090

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776

    Mulhouse, 68200

  • Clinique Jules Verne /ID# 241666

    Nantes, 44300

  • Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682

    Nice, Alpes-Maritimes, 06200

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703

    Nice, 06000

  • Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680

    Nîmes, Gard, 30900

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516

    Paris, 75014

  • CSAPA CAARUD Aurore EGO /ID# 225050

    Paris, 75018

  • CEID Bearn addictions /ID# 221279

    Pau, 64000

  • Csapa Doaur Nevez de Ploermel /Id# 240583

    Ploërmel, Morbihan, 56800

  • Association Tremplin 17 - Saintes /ID# 218708

    Saintes, New Aquitaine, 17100

  • Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678

    Strasbourg, 67000

  • Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701

    Valence, Drome, 26000

Other trials in France

About this study

Official title: New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

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.

Read more

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.

Keywords
Hepatitis C Virus, HCV, glecaprevir/pibrentasvir, Maviret
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04366973
Study groupRoleWhat they receive
Participants with Hepatitis C Virus With or Without TreatmentThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Inclusion visit (Week 0)

Secondary outcomes (17)

  1. 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).

    Measured: Inclusion visit (Week 0)

  2. 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).

    Measured: Inclusion visit (Week 0)

  3. Determinants associated with initiation of HCV treatment

    Criteria for treatment choice or no treatment uptake assessed by physician, patient, and disease characteristics.

    Measured: Inclusion visit (Week 0)

  4. Data and disease characteristics from patients with and without HCV treatment

    Data and disease characteristics from patients with and without HCV treatment.

    Measured: Inclusion visit (Week 0)

  5. Number of participants with HCV Antibodies (HCV Ab)

    Number of participants with HCV Antibodies (HCV Ab).

    Measured: Inclusion visit (Week 0)

  6. Number of participants with HCV RNA

    Number of participants with HCV RNA.

    Measured: Inclusion visit (Week 0)

  7. Time from HCV Ab to HCV RNA

    Time from HCV Ab to HCV RNA.

    Measured: Inclusion visit (Week 0)

  8. Time from HCV RNA to end of treatment

    Time from HCV RNA to end of treatment.

    Measured: Approximately 12 months

  9. Number of participants who completed treatment

    Number of participants who completed treatment.

    Measured: Approximately 12 months

  10. 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.

    Measured: Approximately 12 months

  11. 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.

    Measured: Approximately 12 months

  12. Number of participants achieving sustained viral response at 12 weeks (SVR12)

    Number of participants achieving sustained viral response at 12 weeks (SVR12).

    Measured: Approximately 12 months

  13. Time to SVR12

    Time to SVR12

    Measured: Approximately 12 months

  14. Number of people in charge of patient follow-up

    Number of people in charge of patient follow-up including physicians, nurses, social workers.

    Measured: Approximately 12 months

  15. Percentage of participants with treatment adherence

    Defined as the percentage of participants who have taken the target dose according to participant reporting.

    Measured: Approximately 12 months

  16. Patient Reported Quality of Life

    Anxiety and depression questionnaires and global assessment using visual analog scale.

    Measured: Approximately 12 months

  17. Number of participants with addictive behaviors

    Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires.

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start26 May 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04366973
Sponsor's protocol ID
P20-127
Acronym
NeoVie
Status last verified
Jan 2024
First submitted
28 Apr 2020
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus (HCV), run by AbbVie at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit. (time frame: Inclusion visit (Week 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04366973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.

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