Pulmonary Arterial HypertensionPhase 3NCT02652429
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
A Phase 3 study testing Inhaled Nitric Oxide in people with Pulmonary Arterial Hypertension, run by Bellerophon Pulse Technologies at 17 sites in 2 countries.
Trial summary
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Mar 2016to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States13 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UC Health University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University, Wexner Medical Center
Columbus, Ohio, 43221
Fernando Torres, MD
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073
Intermountain Medical Center
Murray, Utah, 84107
Mount Sinai Beth Israel
New York, New York, 10003
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Cleveland Clinic Florida
Weston, Florida, 33331
Canada4 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y6J4
University of Alberta Hospitals - MAHI
Edmonton, Alberta, T6G2B7
Lawson Clinical Research Services
London, Ontario, N6C2R5
University Health Network
Toronto, Ontario, M5G2C4
About this study
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
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Inhaled Nitric Oxide
- Keywords
- PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric OxideDrug
Also called iNO
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | Pulsed iNO 75 mcg/kg IBW/hour Receives: Drug: Inhaled Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events
Incidence of Serious Adverse Events from baseline to end of study
Measured: 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
Measured: Through Study Completion, anticipated 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Extension
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bellerophon Pulse Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashika Ahmed, MD, Study director, Bellerophon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652429
- Sponsor's protocol ID
- PULSE-PAH-006
- Status last verified
- Feb 2022
- First submitted
- 17 Dec 2015
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02652429
- Acronym / sponsor ID
- PULSE-PAH-006
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Bellerophon Pulse TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Extension
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | Drug: Inhaled Nitric OxidePulsed iNO 75 mcg/kg IBW/hour |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Nitric OxideAlso: iNO | Drug | Inhaled Nitric Oxide (iNO) |
Primary outcome
Incidence of Serious Adverse Events
Time frame: Through Study Completion, anticipated 3 years
Incidence of Serious Adverse Events from baseline to end of study
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashika Ahmed, MD study director
Bellerophon Therapeutics
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled Nitric Oxide in people with Pulmonary Arterial Hypertension, run by Bellerophon Pulse Technologies at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events (time frame: Through Study Completion, anticipated 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.