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NCT01161641 · ClinicalTrials.gov registry record · Phase 1
Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery
A Phase 1 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01161641 is a Phase 1 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 5 participants.
The verdict
NCT01161641, a Phase 1 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children and adults with congenital heart disease for which a palliative procedure known as the "Fontan procedure" has been performed. The loss of serum proteins into the gastrointestinal tract that is associated with PLE can cause serious symptoms and life-threatening complications. A number of clinical studies have suggested that heparin administration can have clinical benefit in children with PLE, however the risk of bleeding associated with the administration of heparin is an important concern and commonly limits its administration. ODSH is a desulfated heparin with minimal anticoagulation properties but which, in pre-clinical studies, appears to have the potential to replace heparin and greatly reduce the risk of bleeding. This open label study is to assess the safety and evidence of therapeutic effect of the administration of ODSH as a 4-day continuous intravenous infusion in patients with an exacerbation of their PLE.
Interventions
- DRUG ODSH at 0.125 mg/kg/h
- DRUG ODSH at 0.375 mg/kg/h
- DRUG ODSH at 0.250 mg/kg/h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161641
The ClinicalTrials.gov registry entry for NCT01161641 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ODSH at 0.125 mg/kg/h is the first listed.
NCT01161641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01161641 about?
NCT01161641 is a clinical study titled "Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery". Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children and adults with congenital heart disease for which a palliative procedure known as the "Fontan procedure" has been performed. The loss of serum proteins into the gastrointestinal tract that is associated wit...
What is the current status of trial NCT01161641?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-07. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01161641?
The interventions under investigation include: ODSH at 0.125 mg/kg/h (DRUG), ODSH at 0.375 mg/kg/h (DRUG), ODSH at 0.250 mg/kg/h (DRUG).
Who is sponsoring clinical trial NCT01161641?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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