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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
Sponsored by
Bellerophon Pulse Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham
  • West Los Angeles VA Healthcare Center
  • University of Colorado Denver
  • Cleveland Clinic Florida
  • University of Maryland Medical Center
  • Mount Sinai Beth Israel
  • Duke University Medical Center
  • UC Health University of Cincinnati
  • Cleveland Clinic
  • Ohio State University, Wexner Medical Center
  • Allegheny General Hospital
  • Fernando Torres, MD
  • Intermountain Medical Center
  • Peter Lougheed Centre
  • University of Alberta Hospitals - MAHI
  • Lawson Clinical Research Services
  • University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled Nitric Oxide (iNO)

Arm Description

Pulsed iNO 75 mcg/kg IBW/hour

Outcomes

Primary Outcome Measures

Incidence of Serious Adverse Events
Incidence of Serious Adverse Events from baseline to end of study
Incidence of INOpulse device malfunction and/or device failure leading to an AE
Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study

Secondary Outcome Measures

Full Information

First Posted
December 17, 2015
Last Updated
February 17, 2023
Sponsor
Bellerophon Pulse Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT02652429
Brief Title
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellerophon Pulse Technologies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open Label Extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide (iNO)
Arm Type
Experimental
Arm Description
Pulsed iNO 75 mcg/kg IBW/hour
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Other Intervention Name(s)
iNO
Primary Outcome Measure Information:
Title
Incidence of Serious Adverse Events
Description
Incidence of Serious Adverse Events from baseline to end of study
Time Frame
Through Study Completion, anticipated 3 years
Title
Incidence of INOpulse device malfunction and/or device failure leading to an AE
Description
Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study
Time Frame
Through Study Completion, anticipated 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashika Ahmed, MD
Organizational Affiliation
Bellerophon Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UC Health University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University, Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Fernando Torres, MD
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y6J4
Country
Canada
Facility Name
University of Alberta Hospitals - MAHI
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Lawson Clinical Research Services
City
London
State/Province
Ontario
ZIP/Postal Code
N6C2R5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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