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

Primary Purpose

Hypertension, Pulmonary, Ventricular Dysfunction, Left

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
IK-3001
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring pulmonary hypertension, cardiac surgery, Glenn surgery, fontan surgery, left ventricular assist device, LVAD

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inhaled nitric oxide

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean pulmonary artery pressure (mPAP) in Adult subjects (with LVAD)
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Adult subjects (with LVAD)
Change in central venous pressure (CVP) in Children (with congenital heart disease)
Change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio in Children (with congenital heart disease)

Secondary Outcome Measures

Full Information

First Posted
October 8, 2013
Last Updated
September 8, 2016
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01959828
Brief Title
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: Adults with severe congestive heart failure having LVAD implant 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Keywords
pulmonary hypertension, cardiac surgery, Glenn surgery, fontan surgery, left ventricular assist device, LVAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inhaled nitric oxide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IK-3001
Other Intervention Name(s)
inhaled nitric oxide
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khurram Jamil, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center (Pediatric CV Surgery)
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center (Transplantation)
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
National Center for Child Health and Development
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Tokyo
ZIP/Postal Code
183-8561
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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