Clinical trial NCT03905707: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
Official title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Short Bowel Syndrome
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Detailed description: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activity
* Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

Exclusion Criteria:

* Withdrawal of consent from the lead-in trial
* Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results
* Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening
* Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Safety - Serious Adverse Events
timeFrame: 2 years
measure: Safety - Adverse Events of Special Interest
timeFrame: 2 years
measure: Safety - Changes in blood pressure from baseline
timeFrame: 2 years
measure: Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
timeFrame: 2 years
measure: Immunogenicity - Occurrence of anti-drug antibodies
timeFrame: 2 years
measure: Change in weekly Parenteral Support (PS) volume
timeFrame: 2 years
measure: Number of patients with 20 percent reduction in PS volume
timeFrame: 2 years
measure: Days off PS
timeFrame: 2 years
measure: Weaned off PS
timeFrame: 2 years
measure: Changes in fluid composite effect
timeFrame: 2 years
measure: Energy content (lipids)
timeFrame: 2 years
measure: Energy content (glucose)
timeFrame: 2 years
measure: Energy content (amino acids)
timeFrame: 2 years
measure: Days on PS
timeFrame: 2 years
measure: Number of patients with 40 percent change in PS volume per week
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Children&#39;s Hospital
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Nashville
state: Tennessee
city: Leuven
country: Belgium
facility: UZ Leuven
city: Edmonton
country: Canada
facility: The Royal Alexandra Hospital
city: London
country: Canada
facility: Western University
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Clichy
country: France
facility: Hôpital Beaujon
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt - Med. Klinik I
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Nijmegen
country: Netherlands
facility: UMC Radboud Nijmegen
city: Poznań
country: Poland
facility: Solumed
city: Skawina
country: Poland
facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka
city: Łódź
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
city: Harrow
country: United Kingdom
facility: St Mark&#39;s Hospital
city: London
country: United Kingdom
facility: UCLH Foundation NHS Trust
city: Norwich
country: United Kingdom
facility: University of East Anglia
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Zealand Pharma
name: Zealand Pharma
role: STUDY_DIRECTOR
References: