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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47210
• EU PAS number:
  EUPAS3142
• Study ID:
  47210
• Official title and acronym:
  A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY Study
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Gastroenterologists France, General Practitioners France

Study timelines

Date when funding contract was signed

Actual: 15/07/2013

Study start date

Actual: 13/03/2014

Data analysis start date

Planned: 01/10/2014

Date of interim report, if expected

Actual: 28/04/2015

Date of final study report

Planned: 31/10/2016

Actual: 25/10/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aptalis Pharma

Study protocol

Initial protocol

Ma-PY-HpPK11-01_PYLERA_S_PRO_SAPHARY-RMP_EN 0T-20131104(signé) vf

Updated protocol

amended-protocol-pyr-md-301-amendment-6

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)