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

NCT01959828 | Completed Phase 3

• 1 other identifier: IK-3001-CVS-301
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hypertension, Pulmonary; Ventricular Dysfunction, Left

Keywords

pulmonary hypertension; cardiac surgery; Glenn surgery; fontan surgery; left ventricular assist device; LVAD

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

inhaled nitric oxide

EXPERIMENTAL

Adults: IK-3001 at start dose 20 ppm; may be increased to 40 ppm at the investigator's or subinvestigator's discretion (up to \~ 24 hrs). Children: IK 3001 at start 10 dose ppm; may be increased to 20 ppm at the investigator's or subinvestigator's discretion (up to \~24 hrs). Treatment with IK-3001 will continue until it is clinically indicated to begin the weaning process from IK-3001.

Drug: IK-3001

Interventions

IK-3001 DRUG

Also known as: inhaled nitric oxide

inhaled nitric oxide

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet one of the following criteria:
• Adults, aged 15 to 80 years, with severe congestive heart failure (CHF) and scheduled for left ventricular assist device (LVAD) placement; or
• 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
• Children, aged \< 15 years, with congenital heart disease and scheduled for Glenn surgery; or
• Children, aged \< 15 years, with congenital heart disease and scheduled for Fontan surgery.
• For women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment.
• 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.

You may not qualify if:

• Lung hypoplasia or other pre-existing severe lung disease;
• Planned bi-ventricular support;
• 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;
• Subjects with PH secondary to organic obstructive lesions in pulmonary arteries;
• Subjects not under mechanical ventilation;
• Investigator or subinvestigator decision that the subject is unsuitable for this study.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (7)

Osaka University Hospital

Osaka, 565-0871, Japan

Location

National Cerebral and Cardiovascular Center (Pediatric CV Surgery)

Osaka, 565-8565, Japan

Location

National Cerebral and Cardiovascular Center (Transplantation)

Osaka, 565-8565, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

National Center for Child Health and Development

Tokyo, 157-8535, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, 162-8666, Japan

Location

Tokyo Metropolitan Children's Medical Center

Tokyo, 183-8561, Japan

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Study Officials

• Khurram Jamil, MD

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

JP (7)