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

Browse trials for

• Short Bowel Syndrome 149
• Intestinal Failure 66

Keywords

• Short Bowel Syndrome
• SBS
• Intestinal Failure
• SBS-IF

Study arms

• Experimental
  Apraglutide subcutaneous (SC) injections, once weekly

  Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

  Drug: Apraglutide

Interventions

• DrugApraglutide

  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

Primary outcomes

1. Adverse events (AE)

   System organ class, frequency and severity

   Time frame: From baseline to week 208

2. Clinical chemistry

   Clinical Chemistry panel of analytes will be examined for clinically significant changes.

   Time frame: From baseline to week 208

3. Hematology

   Hematology panel of analytes will be examined for clinically significant changes.

   Time frame: From baseline to week 208

4. Hemostasis

   Hemostasis INR will be examined for clinically significant changes.

   Time frame: From baseline to week 104

5. Urinalysis

   Urinanalysis panel of analytes will be examined for clinically significant changes.

   Time frame: From baseline to week 208

6. Occurrence of clinically relevant changes in vital signs

   * 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.

   Time frame: From baseline to week 208

7. Occurrence of clinically relevant changes in electrocardiogram

   ECG; intervals and rhythm

   Time frame: From baseline to week 208

Secondary outcomes

1. Change from baseline in PS volume

   Time frame: From baseline to week 208

2. Change from baseline in PS frequency

   Change in PS days/week from baseline to week 104

   Time frame: From baseline to week 208

3. Clinically significant changes in PS total energy

   Units: kcal

   Time frame: From baseline to week 208

4. Change from baseline in PS infusion time

   Time frame: From baseline to week 208

5. Percentage of subjects reaching enteral autonomy

   Time frame: From baseline to week 104

6. Change from baseline in body weight

   Units: kg

   Time frame: From baseline to week 104

7. Change from baseline on the Patient Global Impression of Severity (PGIS)

   Time frame: From baseline to week 104

8. Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)

   Time frame: From baseline to week 208

9. Change from baseline on the Patient Global Impression of Change (PGIC)

   Time frame: From baseline to week 208

10. Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)

    Time frame: From baseline to week 208

11. Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)

    Time frame: From baseline to week 208

12. Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)

    Time frame: From baseline to week 208

13. Change from baseline on the Short Form (36) Health Survey (SF-36)

    Time frame: From baseline to week 208

14. Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

    Time frame: From baseline to week 208