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Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery

2014-08-27 03:12:16 | BioPortfolio

Summary

Protein Losing Enteropathy (PLE) is a serious and sometimes fatal medical condition that may develop in subjects with congenital cardiac disease for which a palliative procedure known as the "Fontan operation" is performed. The loss of protein through the intestine causes refractory hypoalbuminemia. Heparin administration has shown to improve PLE; however the risk of bleeding is important; this risk should be reduced by using ODSH instead of heparin. ODSH is a desulfated heparin with minimal anticoagulation properties. This open label study is to assess the safety and therapeutic evidence of the administration of ODSH as 4-day continuous intravenous infusion in patients with exacerbation of PLE.

Description

Protein Losing Enteropathy (PLE)is a serious and sometimes fatal condition that develop in after single ventricle palliative surgery. The mechanisms are not well defined or understood; however a recent mechanism has been proposed consistent with the specific loss of heparin sulfate proteoglycans from the basolateral surface of the intestinal epithelial cells during PLE exacerbation. Heparin administration has improved this medical condition as reported in several cases in the medical literature with improvement or recovery of PLE exacerbations; however the risk of bleeding is high. ODSH ( 2-0, 3-0 desulfated heparin) is a modified heparin that preserves the anti-inflammatory properties of heparin with minimal or no anticoagulation effects. ODSH has been studied in the rodent model of PLE an has shown improvement of PLE due to restoration of heparan sulfate and Syndecan 1 with stabilization of the cell matrix of the capillary endothelium.

This open label study will enroll 9 subjects with a dose escalation (3 doses) study design. Three subjects will be treated with the lower dose of ODSH then an ad hoc safety committee will assess the safety information to recommend on advancing to the next higher dose of ODSH; until the 3 dose cohorts are completed. Plasma albumin and fecal alpha 1 antitrypsin; both biological markers of protein loss through the intestinal lumen in this condition, are the primary variables studied. The effect of ODSH on the associated diarrhea, abdominal pain, and peripheral edema or ascitis will also be evaluated using visual/categorical scales for the patients to assess symptoms and clinical evaluation by the investigator.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Exacerbation of Protein Losing Enteropathy

Intervention

ODSH ( 2-0, 3-0 desulfated heparin)

Location

Department of Cardiology, Children's Hospital Boston
Boston
Massachusetts
United States
02115

Status

Recruiting

Source

ParinGenix

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:16-0400

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Medical and Biotech [MESH] Definitions

Pathological conditions in the INTESTINES that are characterized by the gastrointestinal loss of serum proteins, including SERUM ALBUMIN; IMMUNOGLOBULINS; and at times LYMPHOCYTES. Severe condition can result in HYPOGAMMAGLOBULINEMIA or LYMPHOPENIA. Protein-losing enteropathies are associated with a number of diseases including INTESTINAL LYMPHANGIECTASIS; WHIPPLE'S DISEASE; and NEOPLASMS of the SMALL INTESTINE.

A sulfated plasma protein with the MW of approximately 66kDa that resembles ANTITHROMBIN III. The protein is an inhibitor of thrombin in plasma and is activated by dermatan sulfate or heparin. It is a member of the serpin superfamily.

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Coagulant substances inhibiting the anticoagulant action of heparin.

A heparin fraction with a mean molecular weight of 4500 daltons. It is isolated from porcine mucosal heparin and used as an antithrombotic agent. (From Merck Index, 11th ed)

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