ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 73116
| General | |
| Identification | |
| Detailed name | Cohort of Liver Transplant Patients with Hepatitis C Recurrence Treated with Direct Acting Antiviral Agent |
| Sign or acronym | ANRS CO23 CUPILT |
| General Aspects | |
| Medical area |
Biology Gastroenterology et hepatology Infectious diseases |
| Health determinants |
Iatrogenic Medicine |
| Keywords | drug interactions, direct acting antivirals, liver transplant, HCV |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pageaux |
| Surname | Georges-Philippe |
| Address |
CHRU Saint Eloi 80 av Augustin Fliche 34295 MONTPELLIER CEDEX 5 |
| Phone | +33 (0)4 67 33 73 90 |
| gp-pageaux@chu-montpellier.fr | |
| Organization | Montpellier University Hospital |
| Name of the director | Duclos Vallée |
| Surname | Jean-Charles |
| Address |
12-14 Avenue Paul Vaillant Couturier 94800 Villejuif |
| Phone | +33 (0)1 45 59 32 55 |
| jean-charles.duclos-vallee@pbr.aphp.fr | |
| Unit | Joint Research Unit U785 |
| Organization | Paul Brousse Hepatobiliary Centre |
| Name of the director | Coilly |
| Surname | Audrey |
| Address |
12-14 Avenue Paul Vaillant Couturier 94800 Villejuif |
| Phone | +33 (0)1 45 59 33 36 |
| audrey.coilly@pbr.aphp.fr | |
| Unit | Joint Research Unit U785 |
| Organization | Paul Brousse Hepatobiliary Centre |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | ANRS, Inserm |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Inserm-ANRS |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Service d’Hépatogastroentérologie, Hôpital Saint-Eloi, Montpellier |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Centre Hépato-Biliaire Paul Brousse |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Database objective | |
| Main objective | To investigate the efficacy, defined as obtaining a sustained virology response after 12 weeks of completing treatment, of direct acting agents (DAA) with or without peginterferon and/or ribavirin therapy, in liver transplant patients with Hepatitis C virus (HCV) infection recurrence following liver transplantation, regardless of genotype or response to previous treatment. |
| Inclusion criteria |
– elderly subjects over 18 years old
– transplanted liver – infected with HCV before transplantation – presenting Hepatitis C virus (HCV) infection recurrence (regardless of genotype) with detectable HCV RNA at baseline – received or receiving antiviral therapy with a direct antiviral agent or having completed treatment but still being monitored (within 48 weeks after completing treatment) – member of a social security scheme – signed consent form N.B.: Included – multiple transplants – treatment-naive or failed treatment patients, before and after transplantation, regardless of previous model – patients with HIV or HBV co-infection – all stages of hepatic fibrosis |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France and Belgium |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2013 |
| Date of last collection (YYYY or MM/YYYY) | 06/2018 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 800 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Year of birth; sex; details of ethnicity and skin colour; unresolved medical comorbidities at baseline; details regarding pre-transplantation; donor; transplantation; details regarding post-transplantation treatments and complications; height; weight; treatment tolerance; treatments (– immunosuppressants (collected up to 4 weeks following DAA treatment completion) – antiretroviral treatment – hematopoietic growth factors – corrective action plans for adverse effects and Grade 3 serious adverse effects – any other treatments deemed significant by the investigator) |
| Biological data (detail) | FBC; INR platelets; Albumin; TP; ALT; AST; GGT PAL; total bilirubin; RNA and HCV; residual immunosuppressive concentration; if HIV+: Viral load and CD4 count |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Blood cells isolated |
| Details of biobank content | Plasma and serum for DNA extraction and cell bank. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Treatment duration and 48 weeks following treatment completion. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/pubmed-ANRSCO23 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge and Inserm–ANRS sponsor. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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