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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Pharmacokinetic study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicenter, open-label, single-arm, clinical trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BD08) bismuth subcitrate, tetracycline and metronidazole

  bismuth subcitrate, tetracycline and metronidazole

Population studied

• Short description of the study population:
  Patients who have been prescribed Pylera®.; ; To be eligible, subjects must meet all of the following criteria:; 1. Men and women 18 years of age and older who have received a prescription for Pylera® therapy from the Investigator; 2. 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; ; Subjects with any of the following conditions must be excluded from this study:; 1. Women who are pregnant or nursing; 2. Any concern by the Investigator regarding the safe participation of the subject in the study or for any other reason the Investigator considers the subject inappropriate for participation in the study
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To verify the absence of accumulation of bismuth in subjects prescribed Pylera, a pharmacokinetic approach in a real-life setting
• Outcomes:
  Post-treatment whole blood and plasma concentration of bismuth (metal) will be described after subtraction of the baseline value for each subject. Individual observed results will also be classified as « above » or « bellow » the threshold of 50 micrograms per liter for whole blood bismuth concentrations. The safety profile will be assessed in terms of overall adverse events, vitals signs, and concomitant medication usage over 10-days treatment period, as well as at the 4 weeks follow-up period after treatment.The eradication rate of Pylera is defined as the proportion of negative test of diagnostic H. Pylori test conducted at least 28 day following the end of treatment with Pylera.
• Data analysis plan:
  A detailed statistical analysis plan will be performed before database lock using SAS® software. Descriptive statistics including mean, median, standard deviation, minimum, and maximum will be presented for continuous variables. For categorial variables, the number of subjects and percentage within each category will be presented. Bismuth concentrations (Cobs, Cmin) will be described at baseline and at the end of treatment and bismuth accumulation value will be estimated. Proportion of subjects who experienced any/serious adverse events will be assessed, including 95% confidence interval (CI). The eradication rate of Pylera will be calculated from proportion and 95% CI of subjects having negative test of diagnostic H. pylori test at the end of study. An interim analysis of bismuth concentration is planned 18 months after Pylera market launch. No statistical comparisons will be performed.

Documents

Study results

SAPHARY-Abstract of Final study report-v1.0-20161025

Study publications

Guiard E, Lelievre B, Rouyer M, Zerbib F, Diquet B, Mégraud F, Tison F, Bignon …