Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.

Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.

Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.

Open-Label

Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD

Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride

ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD

ODSH Treatment Group

Total

Age, Customized

Sex/Gender, Customized

Region of Enrollment

The primary outcome of the study is "Treatment Failure" as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital.

Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride

0.9% Sodium Chloride

Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm

Randomized, Blinded, ODSH Arm

Incidence of Treatment Failure

Open Label
The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.
After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis.

Open Label

Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.

Placebo Comparator: 0.9% Sodium Chloride

Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.

Overall Study

Claude Bertrand

Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.
Open-Label: ODSH administered open-label

Chronic Obstructive Pulmonary Disease

Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride

Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride

ODSH

Pulmonary Consultants & Primary Care

Wellstar Kennestone Hospital

Louisiana State University Health Sciences Center in Shreveport

Washington Universtiy School of Medicine

The Oregon Clinic

Temple University of the Commonwealth of Higher Education

Methodist Hospital

Michael E. DeBakey VA Medical Center

University of Texas Health Care Center at Tyler

Western Washington Medical Group

University Hospital Gasthuisberg

CHU Liege Domain Universitaire du Sart Tilman

Cliniques Universiaries U.C.L. de Mont-Gondinne

University of Alberta Hospital

Kelowna General Hospital

Vancouver Coastal Health

St. Boniface General Hospital

QE II Health Sciences Centre

Credit Valley Hospital,

The Ottawa Hospital, Civic Campus

University of Toronto

Laval Hospital

Klinik Schillerhohe

Pneumologisches Forschungsinstitut GmbH

Medizinsche Hochschule

Uniklinikum Mainz

Klinikum der LMU Innenstadt

Wojewodzki Szpital Specjalistyczny im. Najswietszej Marii Panny

Samodzielny Publiczny Szpital Kliniczny SUM w Katowicach

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Liniczny nr 1 im Norberta Barlickiego

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, Samodzielny Publiczny Zespol Opieki Zdrowotnej

Samodzielny Publiczny Szpital Klinczny nr 4 W Lublinie

Zespol Opieki Zdrowotnej w Olawie

Wieklopolskie Centrum Chorob Pluc i Gruzlicy

I Klinika Chorob Plus, Instyut Gruzlicy i Chorob Pluc

Miedzyleski Szpital Specjalistyczny w Warszawie

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD

An Open-Label Phase Followed by a Randomized, Double-Blind, Placebo-Controlled Phase in a Study Designed to Evaluate Intravenous 2-O, 3-O Desulfated Heparin (ODSH) in Subjects With Exacerbations of Chronic Obstructive Pulmonary Disease

Cantex Pharmaceuticals

mucopolysaccharide

infark

infarction

mucopolysaccharide/infark

A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD

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