A 104-WEEK, MULTICENTER, SINGLE-ARM, LONG-TERM, PHASE 3 EXTENSION TRIAL INVESTIGATING THE SAFETY AND EFFICACY OF GLEPAGLUTIDE IN ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) COMPLETING THE EASE SBS 2 TRIAL

Conditions

Short bowel syndrome

Brief summary

Incidence and type of AEs, with onset or worsening following Visit 1

Detailed description

Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) (with onset or worsening following Visit 1), Changes from baseline in: - Vital signs - Electrocardiogram, Changes from baseline in: - Hematology - Biochemistry - Urinalysis, Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies), The secondary efficacy endpoints are: Reduction in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction of at least 20% in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction in days on PS ≥ 1 day/week from baseline, The secondary efficacy endpoints are: Reduction in weekly PS volume of 100% (weaned off)

Related papers

No related papers found yet.

Interventions

DRUGGlepaglutide 20.0 mg/mL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and type of AEs, with onset or worsening following Visit 1	—

Secondary

Measure	Time frame
Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) (with onset or worsening following Visit 1), Changes from baseline in: - Vital signs - Electrocardiogram, Changes from baseline in: - Hematology - Biochemistry - Urinalysis, Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies), The secondary efficacy endpoints are: Reduction in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction of at least 20% in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction in days on PS ≥ 1 day/week from baseline, The secondary efficacy endpoints are: Reduction in weekly PS volume of 100% (weaned off)	—

Measure

Time frame

Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) (with onset or worsening following Visit 1), Changes from baseline in: - Vital signs - Electrocardiogram, Changes from baseline in: - Hematology - Biochemistry - Urinalysis, Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies), The secondary efficacy endpoints are: Reduction in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction of at least 20% in weekly PS volume (prescribed) from baseline, The secondary efficacy endpoints are: Reduction in days on PS ≥ 1 day/week from baseline, The secondary efficacy endpoints are: Reduction in weekly PS volume of 100% (weaned off)

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Countries

Belgium, Denmark, France, Germany, Netherlands, Poland

Outcome results

None listed