A Phase 2 Trial Testing ZP1848 in Patients With SBS

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma
• Collaborator: Larix A/S

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