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

NCT00457951 | Terminated Phase 2 Results DMC

• 1 other identifier: PGX-ODSH-2006
• Study Type: interventional
• Target: 158
• Locations: 5 countries
• Sites: 38

Brief Summary

The purpose of this study is to determine whether ODSH, when added to conventional treatment, is more effective in treating COPD exacerbations than conventional therapy alone.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Heparin; ODSH; Exacerbations of COPD

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Failure

  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.

  Time to hospital discharge and 21 days post-treatment, up to 31 days

Study Arms (3)

Open Label

EXPERIMENTAL

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.

Drug: Open-Label

0.9% Sodium Chloride

PLACEBO COMPARATOR

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

Drug: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride

Randomized, Blinded, ODSH Arm

ACTIVE COMPARATOR

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.

Drug: ODSH

Interventions

Open-Label DRUG

ODSH administered open-label

Also known as: PGX-100

Open Label

Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride DRUG

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

Also known as: 0.9% Sodium Chloride Solution Placebo-Control Arm

0.9% Sodium Chloride

ODSH DRUG

Randomized, Blinded, ODSH Arm

Also known as: PGX-100

Randomized, Blinded, ODSH Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients (40 years of age or older) with an established diagnosis of COPD based upon medical history who are being admitted to the hospital to treat an exacerbation of COPD;
• Normal prothrombin time and activated partial thromboplastin time; Platelet count; hemoglobin and hematocrit

You may not qualify if:

• Certain diseases such as:
• asthma;
• left heart failure or pulmonary embolism;
• lung cancer;
• pneumonia
• liver or kidney disease
• blood clotting disorder
• Positive HIV or hepatitis tests
• GI bleeding, physical trauma with bleeding, any disease with bleeding within 60 days of study entry
• Certain medications such as:
• Plavix®
• Warfarin
• Heparin therapy
• Certain antibiotics
• Exacerbations that are too severe (requiring intubation and mechanical ventilation)

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (38)

Pulmonary Consultants & Primary Care

Orange, California, 92868, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Louisiana State University Health Sciences Center in Shreveport

Shreveport, Louisiana, 71130, United States

Location

Washington Universtiy School of Medicine

St Louis, Missouri, 63110, United States

Location

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

Temple University of the Commonwealth of Higher Education

Philadelphia, Pennsylvania, 19140, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

University of Texas Health Care Center at Tyler

Tyler, Texas, 75708, United States

Location

Western Washington Medical Group

Everett, Washington, 98201, United States

Location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Liege Domain Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

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

Yvior, 5530, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Credit Valley Hospital,

Mississauga, Ontario, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

University of Toronto

Toronto, Ontario, H2X-2P4, Canada

Location

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Klinik Schillerhohe

Gerlingen, 70839, Germany

Location

Pneumologisches Forschungsinstitut GmbH

Großhansdorf, 22927, Germany

Location

Medizinsche Hochschule

Hanover, 30625, Germany

Location

Uniklinikum Mainz

Mainz, 55101, Germany

Location

Klinikum der LMU Innenstadt

München, 80336, Germany

Location

Wojewodzki Szpital Specjalistyczny im. Najswietszej Marii Panny

Częstochowa, 42-200, Poland

Location

Samodzielny Publiczny Szpital Kliniczny SUM w Katowicach

Katowice, 40-752, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

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

Lodz, 90-153, Poland

Location

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

Lublin, 20-718, Poland

Location

Samodzielny Publiczny Szpital Klinczny nr 4 W Lublinie

Lublin, 20-954, Poland

Location

Zespol Opieki Zdrowotnej w Olawie

Oława, 55-200, Poland

Location

Wieklopolskie Centrum Chorob Pluc i Gruzlicy

Poznan, 60-569, Poland

Location

I Klinika Chorob Plus, Instyut Gruzlicy i Chorob Pluc

Warsaw, 01-138, Poland

Location

Miedzyleski Szpital Specjalistyczny w Warszawie

Warsaw, 04-749, Poland

Location

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wroclaw, 50-417, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

PGX-ODSH-2006, Ph II in patients with exacerbation of COPD. There were no safety issues. An interim analysis demonstrated lack of efficacy for the primary and secondary endpoints; therefore, Cantex terminated the study on August 11, 2009.

Results Point of Contact

• Title: Zahra Masoud
• Organization: Chimerix

zmasoud@chimerix.com

763-300-0559

Study Officials

• Tobias Welte, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2007
• First Posted: April 9, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 2, 2021
• Results First Posted: December 16, 2016

Record last verified: 2016-10

Locations

DE (5); BE (3); PL (11); US (10); CA (9)