Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Condition(s) studied

Investigational drug(s) / intervention(s)

Apraglutide: Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Study summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Eligibility

Primary outcome measure(s)

• Adverse events (AE) — From baseline to week 208
  System organ class, frequency and severity
• Clinical chemistry — From baseline to week 208
  Clinical Chemistry panel of analytes will be examined for clinically significant changes.
• Hematology — From baseline to week 208
  Hematology panel of analytes will be examined for clinically significant changes.
• Hemostasis — From baseline to week 104
  Hemostasis INR will be examined for clinically significant changes.
• Urinalysis — From baseline to week 208
  Urinanalysis panel of analytes will be examined for clinically significant changes.
• Occurrence of clinically relevant changes in vital signs — From baseline to week 208
  * Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.
• Occurrence of clinically relevant changes in electrocardiogram — From baseline to week 208
  ECG; intervals and rhythm

Trial sites (66)

+ 26 more sites — see the full list on the official registry below.

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