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Trial record 8 of 39 for:    short bowel syndrome | Recruiting, Not yet recruiting, Available Studies

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS (EASE SBS 2)

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ClinicalTrials.gov Identifier: NCT03905707
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

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.


Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: glepaglutide Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 5, 2019
Estimated Primary Completion Date : November 5, 2022
Estimated Study Completion Date : November 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glepaglutide SC injections twice weekly

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.

In this long term safety study, there is no placebo arm.

Drug: glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Other Name: ZP1848

Experimental: Glepaglutide SC injections once weekly and placebo once weekly

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.

In this long term safety study, there is no placebo arm.

Drug: glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Other Name: ZP1848




Primary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: 2 years ]
    Incidence and type of Adverse Events


Secondary Outcome Measures :
  1. Safety - Serious Adverse Events [ Time Frame: 2 years ]
    Incidence and type of Serious Adverse Events

  2. Safety - Adverse Events of Special Interest [ Time Frame: 2 years ]
    Incidence and type of Adverse Events of Special Interest

  3. Safety - Changes in blood pressure from baseline [ Time Frame: 2 years ]
    Changes in systolic and diastolic blood pressure will be reported

  4. Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) [ Time Frame: 2 years ]
    Number of patients with clinically significant changes in ECG will be reported

  5. Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 2 years ]
    Occurrence of antibodies against glepaglutide

  6. Change in weekly Parenteral Support (PS) volume [ Time Frame: 2 years ]
    Change in weekly PS volume from baseline

  7. Number of patients with 20 percent reduction in PS volume [ Time Frame: 2 years ]
    Achieving at least 20 percent reduction in weekly PS volume from baseline

  8. Days off PS [ Time Frame: 2 years ]
    Achieving 1 or more days per week off PS

  9. Weaned off PS [ Time Frame: 2 years ]
    Reduction in weekly PS volume of 100 percent (weaned off)

  10. Changes in fluid composite effect [ Time Frame: 2 years ]
    Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline

  11. Energy content (lipids) [ Time Frame: 2 years ]
    Change in lipids content (in kcal/L or kjoule/L) of PS from baseline

  12. Energy content (glucose) [ Time Frame: 2 years ]
    Change in glucose content (in kcal/L or kjoule/L) of PS from baseline

  13. Energy content (amino acids) [ Time Frame: 2 years ]
    Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline

  14. Days on PS [ Time Frame: 2 years ]
    Change in number of days on PS per week from baseline

  15. Number of patients with 40 percent change in PS volume per week [ Time Frame: 2 years ]
    Achieving 40 percent in PS volume from baseline



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905707


Contacts
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Contact: Senior Clinical Trial Manager +4588773600 cll@zealandpharma.com
Contact: Clinical Trial Manager +4588773600 teg@zealandpharma.com

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Sponsors and Collaborators
Zealand Pharma
Investigators
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Study Director: Zealand Pharma Zealand Pharma

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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03905707     History of Changes
Other Study ID Numbers: ZP1848-17127
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Disease
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins