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A Phase 2 Trial Testing ZP1848 in Patients With SBS (glepaglutide)

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ClinicalTrials.gov Identifier: NCT02690025
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Larix A/S
Information provided by (Responsible Party):
Zealand Pharma

Brief Summary:
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: ZP1848 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial Testing ZP1848 in Patients With SBS
Study Start Date : February 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ZP1848 High dose
s.c. administration of high dose
Drug: ZP1848
Experimental: ZP1848 Medium dose
s.c. administration of medium dose
Drug: ZP1848
Experimental: ZP1848 Low dose
s.c. administration of low dose
Drug: ZP1848



Primary Outcome Measures :
  1. The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  2. Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  3. Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  4. Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  5. Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  6. Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  7. Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  8. Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  9. Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  10. Change in SF-36 score [ Time Frame: 3 weeks ]
  11. Incidence of Adverse Events [ Time Frame: 15 weeks ]
  12. Incidence of Anti Drug Antibodies [ Time Frame: 15 weeks ]
  13. Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]
  14. Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods [ Time Frame: 3 weeks ]


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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:

  • Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
  • Age ≥ 18 years and ≤ 90 years
  • Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago
  • A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS
  • Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study.
  • Stable body weight (<5% weight deviance in the three months prior to screening)

Exclusion Criteria:

  • Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator
  • Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator.
  • Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization
  • Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
  • History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded)
  • eGFR (by the MDRD formula) <30 mL/min/1.73 m2
  • Clinically meaningful renal disease as judged by the Investigator

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): NCT02690025


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Zealand Pharma
Larix A/S
Investigators
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Study Director: Gertrud Koefoed Rasmussen, MSc Zealand Pharma A/S
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT02690025    
Other Study ID Numbers: ZP1848-15073
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes