Status: FinalisedLast updated on: 25/06/2019
1. Study identification
EU PAS Register NumberEUPAS3142
Official titleA Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study
Study title acronymSAPHARY
Study typeOther: Clinical Pharmacokinetics
Brief description of the studyThe primary objective of the study is to verify the absence of accumulation of bismuth in subjects prescribed Pylera®. The study is a single-arm, open label trial in 200 presumed Helicobacter Pylori-positive subjects and is restricted to centers in France. This study has an anticipated recruitment period of 24 months. Eligible subjects will stay in study for approximately 6 weeks. Following identification of participating general practice and specialist study centers, subjects deemed eligible for study will be identified and may be enrolled. To assess eradication, subjects will complete a diagnostic H. pylori test (breath test, biopsy, or other test at the discretion of the Investigator) following a period of at least 28 days after the end of treatment. Subjects will provide two blood samples for assessment of plasma and whole blood bismuth concentrations, with one sample provided prior to start of Pylera® treatment and one sample provided upon completion of the 10-day treatment with Pylera®. If accumulation of bismuth is detected (defined as whole blood bismuth concentration exceeding 50 μg/L), subjects will be contacted to immediately return to the laboratory to draw a third verification sample and will be referred for potential inclusion and follow-up in a separate intensive monitoring program. In case of a neurological adverse event indicative of bismuth encephalopathy blood samples will be as quickly processed as possible. A diagnostic H. Pylori test to assess H. Pylori eradication should be repeated on one single occasion at least 28 days post-treatment.
Was this study requested by a regulator?Yes: France, Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name BLIN
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?70
Gastroenterologists, France
General Practitioners, France
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/07/2013
Start date of data collection13/03/2014
Start date of data analysis01/10/2014
Date of interim report, if expected28/04/2015
Date of final study report31/10/201625/10/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAptalis Pharma100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BLIN
First name Patrick
Address line 1Université de Bordeaux
Address line 2Bâtiment du Tondu - Case 41 
Address line 3146 Rue Léo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name BLIN 
First name Patrick 
Address line 1Université de Bordeaux 
Address line 2Bâtiment du Tondu - Case 41 
Address line 3146 Rue Léo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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