NCT01953458

Brief Summary

  • The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis.
  • The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,902

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

12.3 years

First QC Date

September 19, 2013

Last Update Submit

January 30, 2023

Conditions

Viral Hepatitis BViral Hepatitis C

Keywords

Hepatitis B and CANRS HEPATHER French Cohort

Outcome Measures

Primary Outcomes (1)

  • There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.

    * Effectiveness of HCV or HBV treatments: Virological response, seroconversion, loss of agHbS, liver fibrosis or clinical response (including quality of life), safety. * Prognostic factors of HCV or HBV infection: liver fibrosis, cirrhosis, clinical or biological event. * Biomarker studies: Virological response, seroconversion, loss of agHbS, liver fibrosis, clinical or biological event, safety * Cost-effectiveness studies: cost perYLS, cost per QALY

    From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years)

Study Arms (1)

hepatitis C and/or B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HBV-positive patients and/or HCV-positive patients

You may qualify if:

  • HBV-positive patients
  • Chronic hepatitis B defined by a positive HBsAg ( surface antigen of the hepatitis B virus) for at least 6 months
  • Acute hepatitis B defined as a recent appearance (\<6 months) of detectable HBs Ag,
  • Chronic hepatitis B with serological remission HbsAg-negative , HB DNA-negative,
  • With or without association with acute or chronic hepatitis D.
  • HCV-positive patients
  • Chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months and positive HCV-RNA
  • Acute hepatitis C defined by the recent appearance of HCV RNA (less than 6 months) in patients with risk factors (with or without positive antibodies)
  • Patients with cured hepatitis C defined by long-term eradication, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment.

You may not qualify if:

  • HIV co-infected patients are not eligible to the cohort.
  • So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
  • Treatment ongoing hepatitis C during or stopped since less than 3 months
  • Patients end of life
  • Woman whose pregnancy is known

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, France

Location

Related Publications (14)

  • Lotto M, Ramier C, Carrat F, Perieres L, Delaroque-Astagneau E, Nicol J, Marcellin F, Zoulim F, Di Beo V, Bertheau M, Pol S, Protopopescu C, Bourliere M, Carrieri P; ANRS/AFEF CO22 HEPATHER Study Group. Mortality risk in migrant and non-migrant individuals with chronic hepatitis B virus infection: a French hospital-based cohort study (ANRS CO22 HEPATHER). BMC Glob Public Health. 2025 Jul 1;3(1):58. doi: 10.1186/s44263-025-00173-7.

    PMID: 40598581DERIVED

  • Barre T, Parlati L, Bourliere M, Ramier C, Marcellin F, Protopopescu C, Di Beo V, Moins C, Dorival C, Nicol J, Zucman-Rossi J, Mathurin P, Larrey D, Boursier J, Carrat F, Carrieri P; ANRS/AFEF Hepather Study group. Socioeconomic Deprivation Weighs Heavily on Liver Fibrosis and Mortality After Hepatitis C Cure (ANRS CO22 Hepather). J Viral Hepat. 2024 Dec;31(12):830-846. doi: 10.1111/jvh.14006. Epub 2024 Sep 10.

    PMID: 39252600DERIVED

  • Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, Zoulim F, de Ledinghen V, Samuel D, Mathurin P, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F. External Validation of LCR1-LCR2, a Multivariable Hepatocellular Carcinoma Risk Calculator, in a Multiethnic Cohort of Patients With Chronic Hepatitis B. Gastro Hep Adv. 2022 May 25;1(4):604-617. doi: 10.1016/j.gastha.2022.02.008. eCollection 2022.

    PMID: 39132068DERIVED

  • Barre T, Bourliere M, Parlati L, Ramier C, Marcellin F, Protopopescu C, Di Beo V, Cagnot C, Dorival C, Nicol J, Zoulim F, Carrat F, Carrieri P; ANRS/AFEF Hepather Study group. Hepatitis C virus cure from direct-acting antivirals and mortality: Are people with and without a history of injection drug use in the same boat? (ANRS CO22 Hepather cohort). Drug Alcohol Rev. 2024 Mar;43(3):718-731. doi: 10.1111/dar.13802. Epub 2023 Dec 22.

    PMID: 38133601DERIVED

  • Carrieri P, Bourliere M, Di Beo V, Lusivika-Nzinga C, Ramier C, Antwerpes S, Protopopescu C, Lacombe JM, Pol S, Fontaine H, Mourad A, Carrat F, Duracinsky M, Marcellin F; ANRS/AFEF HEPATHER Study Group. Impaired health-related quality of life in the HCV cure era: who is concerned? (ANRS CO22 HEPATHER French cohort). Qual Life Res. 2023 Dec;32(12):3427-3438. doi: 10.1007/s11136-023-03496-w. Epub 2023 Aug 16.

    PMID: 37587323DERIVED

  • Sotty J, Bablon P, Lekbaby B, Augustin J, Girier-Dufournier M, Langlois L, Dorival C, Carrat F, Pol S, Fontaine H, Sarica N, Neuveut C, Housset C, Kremdsorf D, Schnuriger A, Soussan P. Diversity of the nucleic acid forms of circulating HBV in chronically infected patients and its impact on viral cycle. Hepatol Int. 2022 Dec;16(6):1259-1272. doi: 10.1007/s12072-022-10389-6. Epub 2022 Aug 4.

    PMID: 35927368DERIVED

  • Barre T, Carrat F, Ramier C, Fontaine H, Di Beo V, Bureau M, Dorival C, Larrey D, Delarocque-Astagneau E, Mathurin P, Marcellin F, Petrov-Sanchez V, Cagnot C, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Cannabis use as a factor of lower corpulence in hepatitis C-infected patients: results from the ANRS CO22 Hepather cohort. J Cannabis Res. 2022 Jun 11;4(1):31. doi: 10.1186/s42238-022-00138-9.

    PMID: 35690798DERIVED

  • Pageaux GP, Nzinga CL, Ganne N, Samuel D, Dorival C, Zoulim F, Cagnot C, Decaens T, Thabut D, Asselah T, Mathurin P, Habersetzer F, Bronowicki JP, Guyader D, Rosa I, Leroy V, Chazouilleres O, de Ledinghen V, Bourliere M, Causse X, Cales P, Metivier S, Loustaud-Ratti V, Riachi G, Alric L, Gelu-Simeon M, Minello A, Gournay J, Geist C, Tran A, Abergel A, Portal I, d'Alteroche L, Raffi F, Fontaine H, Carrat F, Pol S; French ANRS CO22 Hepather Cohort. Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis. BMC Infect Dis. 2022 Jan 27;22(1):94. doi: 10.1186/s12879-022-07076-0.

    PMID: 35086481DERIVED

  • Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, de Ledinghen V, Zoulim F, Samuel D, Mathurin P, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F. External validation of LCR1-LCR2, a multivariable HCC risk calculator, in patients with chronic HCV. JHEP Rep. 2021 Apr 24;3(4):100298. doi: 10.1016/j.jhepr.2021.100298. eCollection 2021 Aug.

    PMID: 34142073DERIVED

  • Barre T, Ramier C, Di Beo V, Carrat F, Fontaine H, Marcellin F, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Liver fibrosis and all-cause mortality in chronic HCV-infected diabetic patients: A paradoxical association? (ANRS CO22 HEPATHER). Liver Int. 2021 Jul;41(7):1694-1698. doi: 10.1111/liv.14949. Epub 2021 May 28. No abstract available.

    PMID: 33993651DERIVED

  • Chalouni M, Pol S, Sogni P, Fontaine H, Lacombe K, Marc-Lacombe J, Esterle L, Dorival C, Bourliere M, Bani-Sadr F, de Ledinghen V, Zucman D, Larrey D, Salmon D, Carrat F, Wittkop L; ANRS CO13 HEPAVIH and ANRS CO22 HEPATHER cohort study groups. Increased mortality in HIV/HCV-coinfected compared to HCV-monoinfected patients in the DAA era due to non-liver-related death. J Hepatol. 2021 Jan;74(1):37-47. doi: 10.1016/j.jhep.2020.08.008. Epub 2020 Aug 14.

    PMID: 32798585DERIVED

  • Laurain A, Metivier S, Haour G, Larrey D, Dorival C, Hezode C, Zoulim F, Marcellin P, Bourliere M, Zarski JP, Thabut D, Alric L, Ganne-Carrie N, Cales P, Bronowicki JP, Riachi G, Geist C, Causse X, Abergel A, Chazouilleres O, Mathurin P, Guyader D, Samuel D, Tran A, Loustaud-Ratti V, Petrov-Sanchez V, Diallo A, Luzivika-Nzinga C, Fontaine H, Carrat F, Pol S; ANRS/AFEF HEPATHER study group. Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort. BMC Infect Dis. 2019 Apr 2;19(1):300. doi: 10.1186/s12879-019-3923-5.

    PMID: 30940090DERIVED

  • Carrat F, Fontaine H, Dorival C, Simony M, Diallo A, Hezode C, De Ledinghen V, Larrey D, Haour G, Bronowicki JP, Zoulim F, Asselah T, Marcellin P, Thabut D, Leroy V, Tran A, Habersetzer F, Samuel D, Guyader D, Chazouilleres O, Mathurin P, Metivier S, Alric L, Riachi G, Gournay J, Abergel A, Cales P, Ganne N, Loustaud-Ratti V, D'Alteroche L, Causse X, Geist C, Minello A, Rosa I, Gelu-Simeon M, Portal I, Raffi F, Bourliere M, Pol S; French ANRS CO22 Hepather cohort. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019 Apr 6;393(10179):1453-1464. doi: 10.1016/S0140-6736(18)32111-1. Epub 2019 Feb 11.

    PMID: 30765123DERIVED

  • Pol S, Bourliere M, Lucier S, Hezode C, Dorival C, Larrey D, Bronowicki JP, Ledinghen VD, Zoulim F, Tran A, Metivier S, Zarski JP, Samuel D, Guyader D, Marcellin P, Minello A, Alric L, Thabut D, Chazouilleres O, Riachi G, Bourcier V, Mathurin P, Loustaud-Ratti V, D'Alteroche L, Fouchard-Hubert I, Habersetzer F, Causse X, Geist C, Rosa I, Gournay J, Saillard E, Billaud E, Petrov-Sanchez V, Diallo A, Fontaine H, Carrat F; ANRS/AFEF HEPATHER study group. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. J Hepatol. 2017 Jan;66(1):39-47. doi: 10.1016/j.jhep.2016.08.021. Epub 2016 Sep 10.

    PMID: 27622858DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma and urine

MeSH Terms

Conditions

Hepatitis BHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Officials

  • Stanislas POL, MD, PhD

    Hôpital Cochin, PARIS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

October 1, 2013

Study Start

August 6, 2012

Primary Completion

December 1, 2024

Study Completion

December 31, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

FR(1)