Trials Sponsors Conditions Drugs Pricing

Conditions

Short bowel syndrome Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

Incidence and type of Adverse Events (AEs)
For AEs with onset or worsening following Visit 1
After 108 weeks

Secondary Outcomes (50)

Incidence and type of Serious Adverse Events (SAEs)
After 108 weeks
Incidence and type of Adverse Events of Special Interest (AESIs)
After 108 weeks
Change in body temperature
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in heart rate
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in blood pressure
Week 0 in lead-in trial (EASE SBS 1), Week 108
+45 more secondary outcomes

Study Arms (1)

once-weekly glepaglutide

EXPERIMENTAL

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Drug: Glepaglutide

Interventions

GlepaglutideDrug

Glepaglutide will be delivered in a single-use autoinjector.

Also known as: ZP1848

once-weekly glepaglutide

Glepaglutide 20.0 mg/mLType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Glepaglutide 20.0 mg/mL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Glepaglutide 20.0 mg/mL
Named ingredient: glepaglutide
View registry record

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Informed consent obtained before any trial-related activity
Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

You may not qualify if:

Sponsors & Collaborators

Zealand Pharma A/S
Industrylead
Zealand Pharma
Industrylead

Study Sites (19)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Mayo Clinic College of Medicin

Rochester, Minnesota, 55905, United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Vanderbilt University Medical Center, Nashville

Nashville, Tennessee, 68198-3285, United States

Universitair Ziekenhuis Leuven

Leuven, Belgium

Rigshospitalet

Copenhagen, Denmark

Hôpital Beaujon

Clichy, France

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Zealand Pharma
Zealand Pharma
STUDY DIRECTOR

Enrollment

84 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 11, 2021

Study Start

June 16, 2021

Actual (reported)

Primary Completion

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (50)

Study Arms (1)

once-weekly glepaglutide

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (50)

Study Arms (1)

once-weekly glepaglutide

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source records

Locations