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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by INO Therapeutics
Sponsor:
Information provided by (Responsible Party):
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT01959828
First received: October 8, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypertension, Pulmonary
Ventricular Dysfunction, Left
Drug: IK-3001
Phase 3

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

Resource links provided by NLM:


Further study details as provided by INO Therapeutics:

Primary Outcome Measures:
  • Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Adult subjects (with LVAD) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in central venous pressure (CVP) in Children (with congenital heart disease) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Children (with congenital heart disease) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled nitric oxide

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
Other Name: inhaled nitric oxide

Detailed 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.
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959828

Contacts
Contact: Sofia Caamano 908-238-6659 sofia.caamano@ikaria.com

Locations
Japan
National Cerebral and Cardiovascular Center (Pediatric CV Surgery) Recruiting
Osaka, Japan, 565-8565
Principal Investigator: Hajime Ichikawa, MD         
Osaka University Hospital Recruiting
Osaka, Japan, 565-0871
Principal Investigator: Yoshiki Sawa, MD         
National Cerebral and Cardiovascular Center (Transplantation) Recruiting
Osaka, Japan, 565-8565
Principal Investigator: Takeshi Nakatani, MD         
National Center for Child Health and Development Recruiting
Tokyo, Japan, 157-8535
Principal Investigator: Yukihiro Kaneko, MD         
Tokyo Women's Medical University Hospital Recruiting
Tokyo, Japan, 162-8666
Principal Investigator: Kenji Yamazaki, MD         
Tokyo Metropolitan Children's Medical Center Recruiting
Tokyo, Japan, 183-8561
Principal Investigator: Masaru Miura, MD         
The University of Tokyo Hospital Recruiting
Tokyo, Japan, 113-8655
Principal Investigator: Minoru Ono, MD         
Sponsors and Collaborators
INO Therapeutics
Investigators
Study Director: Khurram Jamil, MD INO Therapeutics
  More Information

No publications provided

Responsible Party: INO Therapeutics
ClinicalTrials.gov Identifier: NCT01959828     History of Changes
Other Study ID Numbers: IK-3001-CVS-301
Study First Received: October 8, 2013
Last Updated: January 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by INO Therapeutics:
pulmonary hypertension
cardiac surgery
Glenn surgery
fontan surgery
left ventricular assist device
LVAD

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Ventricular Dysfunction
Ventricular Dysfunction, Left
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014