A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass

Heart Diseases Clinical Trial

Official title:

A Phase II Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Tolerability, Safety, Pharmacokinetics and Efficacy of Intravenous INO-1001 in High Risk Subjects Undergoing Cardiopulmonary Bypass for Coronary Revascularization and/or Valve Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00271167
• Other study ID #: IPC-05-2004
• Status: Terminated
• Phase: Phase 2
• First received: December 29, 2005
• Last updated: March 23, 2015
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: March 2015
• Source: Inotek Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIsrael: Ministry of HealthIndia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.

Description:

Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery.

Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery.

A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.

The following information will be collected: symptoms, vital signs, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.

The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery

• Males and non-pregnant, non-lactating females

Exclusion Criteria:

• Subjects will be required to undergo a full medical review in order to exclude serious medical or psychological illness prior to inclusion

• History of a hypersensitivity reaction to more than three drugs or to mannitol

• Participation in any other investigational study within 30 days of the screening phase

• Known alcohol or drug abuse within the last year

• Treatment with certain restricted medications within a specified time prior to participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases
• Postoperative Complications

Intervention

Drug:
• INO-1001

Locations

Country	Name	City	State
Australia	Ashford Cardiac Clinic / Adelaide Cardiac	Adelaide	South Australia
Australia	St. Vincent's Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
India	Care Hospital	Hyderabad
India	Escorts Heart Institute and Research Centre	New Delhi
Israel	Wolfson Medical Centre	Holon
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Methodist Hospital	Houston	Texas
United States	University of Oklahoma	Oklahoma	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Rapid City Regional Hospital	Rapid City	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Inotek Pharmaceuticals Corporation

Countries where clinical trial is conducted

United States,  Australia,  India,  Israel, 

References & Publications (3)

Khan TA, Ruel M, Bianchi C, Voisine P, Komjáti K, Szabo C, Sellke FW. Poly(ADP-ribose) polymerase inhibition improves postischemic myocardial function after cardioplegia-cardiopulmonary bypass. J Am Coll Surg. 2003 Aug;197(2):270-7. — View Citation

Szabó C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. Review. — View Citation

Virág L, Szabó C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in serious post-operative complications occurring in the first thirty days after surgery.