# Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery

> **NCT01161641** · PHASE1 · TERMINATED · sponsor: **Jazz Pharmaceuticals** · enrollment: 5 (actual)

## Conditions studied

- Protein Losing Enteropathy

## 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

## Key facts

- **NCT ID:** NCT01161641
- **Lead sponsor:** Jazz Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-07
- **Primary completion:** 2012-02
- **Final completion:** 2012-02
- **Target enrollment:** 5 (ACTUAL)
- **Why stopped:** Extremely slow accural due to rarity of medical condition studied.
- **Last updated:** 2021-12-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01161641

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01161641, "Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01161641. Licensed CC0.

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