SAPHARY - A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study

Head :
BLIN Patrick, Bordeaux PharmacoEpi - Université de Bordeaux - Service de Pharmacologie médicale - CIC Bordeaux CIC 1401

Last update : 10/23/2017 | Version : 1 | ID : 73260

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study
Sign or acronym SAPHARY
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CPP: 2012/76, 31/10/2012; EudraCT: 2012-004364-22; CCTIRS: n° 13.427; CNIL: n° 913386
General Aspects
Medical area Gastroenterology et hepatology
Pathology (details) Helicobacter Pylori infection
Health determinants Others (specify)
Others (details) Medicinal product
Keywords Bismuth, neurological adverse event, Pylera, Helicobacter Pylori infection, Bordeaux PharmacoEpi, Service de Pharmacologie médicale
Collaborations
Funding
Funding status Private
Details Aptalis Pharma
Governance of the database
Sponsor(s) or organisation(s) responsible Bordeaux PharmacoEpi - Université de Bordeaux - Service de Pharmacologie médicale - CIC Bordeaux CIC 1401
Organisation status Public
Presence of scientific or steering committees Yes
Scientific investigator(s) (Contact)
Name of the director BLIN
Surname Patrick
Address Bâtiment du Tondu - Case 41
146 Rue Léo Saignat
33076 BORDEAUX Cedex
Phone 05 57 57 46 75
Email patrick.blin@u-bordeaux.fr
Unit Bordeaux PharmacoEpi - Université de Bordeaux - Service de Pharmacologie médicale - CIC Bordeaux CIC 1401
Organization Université de Bordeaux
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 care professionals
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
Additional information regarding sample selection. The study is a single-arm, open label trial in 200 presumed Helicobacter Pylori-positive subjects and is restricted to centers in France. Following identification of participating general practice and specialist study centers, subjects deemed eligible for study will be identified. Subject inclusion in the study will be considered after the decision to treat with Pylera® has been made by investigator. The inclusion visit will be initiated following signature of Informed Consent. The study has an anticipated recruitment period of 24 months. Eligible subjects will stay in study for approximately 6 weeks.
Database objective
Main objective The primary objective of the study is to verify the absence of accumulation of bismuth in subjects prescribed Pylera®, a pharmacokinetic approach in a real-life setting.
Inclusion criteria - Men and women 18 years of age and older who have received a prescription for Pylera® therapy from the Investigator
- Mental and legal ability to give written Informed Consent and judged by the Investigator to be capable of following the procedures outlined within the protocol

Exclusion criteria :
- Women who are pregnant or nursing
- Any concern by the Investigator regarding the safe participating of the subject in the study or for any other reason the Investigator considers the subject inappropriate for participating in the study
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
Pathology B98 - Other specified infectious agents as the cause of diseases classified to other chapters
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2014
Date of last collection (YYYY or MM/YYYY) 2016
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 200 subjects
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Details of collected clinical data Medical charts, clinic charts, nurses' notes, medical correspondence regarding the human subject, subject progress notes, pathology reports, laboratory reports, study worksheets, electronic hospital reporting system
Declarative data (detail) Face to face interview
Details of collected declarative data Advers event
Biological data (detail) Whole blood and plasma concentration of bismuth provided prior to start Pyelra® treatment and upon completion of the 10-day treatment with Pylera®
Presence of a biobank Yes
Contents of biobank Whole blood
Plasma
Details of biobank content Whole blood and plasma sample
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Others
Care consumption (detail) Medicines consumption
Other (detail) Whole blood and plasma concentration of bismuth
Procedures
Data collection method Paper Case Report Form completed by investigator at each follow-up visit.
Classifications used MedDRA coding for neurological and non neurological adverse event (SOC and PT); ATC code
Participant monitoring Yes
Details on monitoring of participants Eligible subjects will stay in the study for approximately 6 weeks with 2 follow-up visits: the end of treatment visit performed after the 10-day treatment with Pylera®, and the end of study visit performed 28 days post-treatment.
Links to administrative sources No
Promotion and access
Promotion
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) A confidentiel study final report has be performed. The ownership of data is defined in a Master Agreement established between the Sponsor, the University of Bordeaux and ADERA (a non-profit making association). The terms of access to the database are to be defined for any third party.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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