Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery
Public ClinicalTrials.gov record NCT01161641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
" An Open Label Pilot Study Evaluating Safety and Evidence of Therapeutic Effect of IV Admin of 2-0, 3-0 Desulfated Heparin, Treatment of Exacerbation of Protein Losing Enteropathy (PLE) Associated With Single Ventricle Palliative Surgery"
Study identification
- NCT ID
- NCT01161641
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Jazz Pharmaceuticals
- Industry
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Interventions
- ODSH at 0.125 mg/kg/h Drug
- ODSH at 0.375 mg/kg/h Drug
- ODSH at 0.250 mg/kg/h Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Jan 31, 2012
- Completion
- Jan 31, 2012
- Last update posted
- Dec 1, 2021
2010 – 2012
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles ( Gastroenterology & Nutrition) | Los Angeles | California | 20027-6016 | — |
| Department of Cardiology, Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| Division of Pediatric Cardiology, University of Michigan Health System | Ann Arbor | Michigan | 48109-5204 | — |
| Sanford Children's ( Sanford Research / USD) | Sioux Falls | South Dakota | 57104-4707 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01161641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2021 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01161641 live on ClinicalTrials.gov.