Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery

Hypertension, Pulmonary Clinical Trial

Official title:

Examination of Safety and Effectiveness of IK-3001 (Nitric Oxide for Inhalation) in Japanese Subjects With Pulmonary Hypertension Associated With Cardiac Surgery - Multi-Center, Open-Label, Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959828
• Other study ID #: IK-3001-CVS-301
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2013
• Last updated: September 8, 2016
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.

Description:

This is a multi-center, open-label, clinical study of the safety and efficacy of IK-3001 in 16 subjects with peri- and post-operative pulmonary hypertension associated with cardiac surgery. Two primary sub-sets of this patient population will be evaluated in this study:

1. Adults with severe congestive heart failure having LVAD implant

2. Children requiring surgery for congenital heart disease with corresponding PH or having Glenn surgery or Fontan surgery for single-ventricle physiology. Children with severe pulmonary hypertension due to congenital heart disease who require inhaled nitric oxide (iNO) pre-operatively may also be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

1. Subjects must meet one of the following criteria:

1. Adults, aged 15 to 80 years, with severe congestive heart failure (CHF) and scheduled for left ventricular assist device (LVAD) placement; or

2. Children, aged < 15 years, scheduled for surgery for congenital heart disease which may associate pulmonary hypertension (PH)(including children with severe PH due to congenital heart failure and with severe hypoxemia secondary to high pulmonary vascular resistance or either a history or a possibility of developing PH crisis, who are deemed by an investigator or subinvestigator to require IK-3001 pre-operatively); or

3. Children, aged < 15 years, with congenital heart disease and scheduled for Glenn surgery; or

4. Children, aged < 15 years, with congenital heart disease and scheduled for Fontan surgery.

2. For women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment.

3. Subjects must give written informed consent. If the subject is a minor the subject's legally acceptable representative (parent or legal guardian) must give written informed consent.

Exclusion Criteria:

1. Lung hypoplasia or other pre-existing severe lung disease;

2. Planned bi-ventricular support;

3. Participation in another clinical trial of an investigational agent within 28 days from the day of informed consent for this study including subjects who are deemed to carry a residual effect of an investigational product lasting more than 28 days from a previous investigational study;

4. Subjects with PH secondary to organic obstructive lesions in pulmonary arteries;

5. Subjects not under mechanical ventilation;

6. Investigator or subinvestigator decision that the subject is unsuitable for this study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• IK-3001

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center (Pediatric CV Surgery)	Osaka
Japan	National Cerebral and Cardiovascular Center (Transplantation)	Osaka
Japan	Osaka University Hospital	Osaka
Japan	National Center for Child Health and Development	Tokyo
Japan	The University of Tokyo Hospital	Tokyo
Japan	Tokyo Metropolitan Children's Medical Center	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD)		Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy	No
Primary	Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Adult subjects (with LVAD)		Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy	No
Primary	Change in central venous pressure (CVP) in Children (with congenital heart disease)		Predose baseline to 24 hours (or final observation, if < 24 hours)(measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy	No
Primary	Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Children (with congenital heart disease)		Predose baseline to 24 hours (or final observation, if < 24 hours) (measured at 1 hour, 4 hours, and 24 hours after initiation of IK-3001 therapy	No