A Phase 2 Trial Testing ZP1848 in Patients With SBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZP1848 High dose

s.c. administration of high dose

Group Type EXPERIMENTAL

ZP1848

Intervention Type DRUG

ZP1848 Medium dose

s.c. administration of medium dose

Group Type EXPERIMENTAL

ZP1848

Intervention Type DRUG

ZP1848 Low dose

s.c. administration of low dose

Group Type EXPERIMENTAL

ZP1848

Intervention Type DRUG

Interventions

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ZP1848

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No