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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: Clinical Trial Phase 1 study, sponsored by Jazz Pharmaceuticals.
NCT01161641 is a Phase 1 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical Improvement of signs \& symptoms of PLE such as diarrhea, abdominal pain, peripheral edema, and ascites. Visual/categorical scales will be used by the study subjects and the investigators to assess diarrhea/abdominal pain intensity as well as The Global Impression of Improvement. The investigator will assess peripheral edema and ascites.
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 |
Why NCT01161641 stopped before completion
NCT01161641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which ODSH at 0.125 mg/kg/h is the first listed.
NCT01161641 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01161641's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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