NCT02652429

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_3

Geographic Reach
2 countries

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2022

Enrollment Period

7.1 years

First QC Date

December 17, 2015

Last Update Submit

February 17, 2023

Conditions

Pulmonary Arterial Hypertension

Keywords

PAHPulmonary Arterial HypertensionInhaled Nitric OxideiNO

Outcome Measures

Primary Outcomes (2)

  • Incidence of Serious Adverse Events

    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

    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

Study Arms (1)

Inhaled Nitric Oxide (iNO)

EXPERIMENTAL

Pulsed iNO 75 mcg/kg IBW/hour

Drug: Inhaled Nitric Oxide

Interventions

Inhaled Nitric OxideDRUG
Also known as: iNO
Inhaled Nitric Oxide (iNO)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UC Health University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Fernando Torres, MD

Dallas, Texas, 75390, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y6J4, Canada

Location

University of Alberta Hospitals - MAHI

Edmonton, Alberta, T6G2B7, Canada

Location

Lawson Clinical Research Services

London, Ontario, N6C2R5, Canada

Location

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ashika Ahmed, MD

    Bellerophon Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Label Extension
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

January 11, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2023

Study Completion

December 1, 2023

Last Updated

February 21, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(13)CA(4)