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Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02652429
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

Brief Summary:
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Inhaled Nitric Oxide Phase 3

Detailed Description:
An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Inhaled Nitric Oxide (iNO)
Pulsed iNO 75 mcg/kg IBW/hour
Drug: Inhaled Nitric Oxide
Other Name: iNO




Primary Outcome Measures :
  1. Incidence of Serious Adverse Events [ Time Frame: Through Study Completion, anticipated 3 years ]
    Incidence of Serious Adverse Events from baseline to end of study

  2. Incidence of INOpulse device malfunction and/or device failure leading to an AE [ Time Frame: Through Study Completion, anticipated 3 years ]
    Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
  • PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
  • Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
  • All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
  • Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.

Exclusion Criteria:

  • Subjects who require treatment with riociguat
  • Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652429


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, New York
Mount Sinai Beth Israel
New York, New York, United States, 10003
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
UC Health University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Canada, Alberta
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y6J4
University of Alberta Hospitals - MAHI
Edmonton, Alberta, Canada, T6G2B7
Canada, Ontario
Lawson Clinical Research Services
London, Ontario, Canada, N6C2R5
University Health Network
Toronto, Ontario, Canada, M5G2C4
Sponsors and Collaborators
Bellerophon Pulse Technologies
Investigators
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Study Director: Hunter Gilles, MD Bellerophon Therapuetics

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Responsible Party: Bellerophon Pulse Technologies
ClinicalTrials.gov Identifier: NCT02652429    
Other Study ID Numbers: PULSE-PAH-006
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bellerophon ( Bellerophon Pulse Technologies ):
PAH
Pulmonary Arterial Hypertension
Inhaled Nitric Oxide
iNO
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents