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

February 17, 2023 updated by: Bellerophon Pulse Technologies

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y6J4
        • Peter Lougheed Centre
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta Hospitals - MAHI
    • Ontario
      • London, Ontario, Canada, N6C2R5
        • Lawson Clinical Research Services
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90073
        • West Los Angeles VA Healthcare Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • New York
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • UC Health University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43221
        • Ohio State University, Wexner Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • Fernando Torres, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Nitric Oxide (iNO)
Pulsed iNO 75 mcg/kg IBW/hour
Drug: Inhaled Nitric Oxide
Other Names:
  • iNO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Serious Adverse Events
Time Frame: Through Study Completion, anticipated 3 years
Incidence of Serious Adverse Events from baseline to end of study
Through Study Completion, anticipated 3 years
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
Through Study Completion, anticipated 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bellerophon Pulse Technologies

Investigators

  • Study Director: Ashika Ahmed, MD, Bellerophon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSE-PAH-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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