A Phase 2 Trial Testing ZP1848 in Patients With SBS

Short Bowel Syndrome Clinical Trial

— glepaglutide  

Official title:

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690025
• Other study ID #: ZP1848-15073
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2016
• Last updated: June 20, 2017
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome

Intervention

Drug:
• ZP1848

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Zealand Pharma	Larix A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 weeks
Secondary	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		3 weeks
Secondary	Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods		3 weeks
Secondary	Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods		3 weeks
Secondary	Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods		3 weeks
Secondary	Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods		3 weeks
Secondary	Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods		3 weeks
Secondary	Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods		3 weeks
Secondary	Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods		3 weeks
Secondary	Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods		3 weeks
Secondary	Change in SF-36 score		3 weeks
Secondary	Incidence of Adverse Events		15 weeks
Secondary	Incidence of Anti Drug Antibodies		15 weeks
Secondary	Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods		3 weeks
Secondary	Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods		3 weeks