Ignite Creation Date:
2024-05-05 @ 11:09 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01265888
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2010-12-20
Brief Title:
Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl
Sponsor:
Geno LLC
Organization:
Geno LLC
Study Overview
Official Title:
A Phase 2 Open-Label Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension PAH WHO Group 1 and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis PH-IPF WHO Group 3 Using Inhaled GeNOsyl
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHiano
Brief Summary:
A Phase 2 open label dose escalation study to find the minimally and maximum effective dose dose beyond which no further effect on PVR is seen of inhaled nitric oxide generated by the GeNOsyl System compared to placebo
Detailed Description:
Up to 54 subjects undergoing RHC are planned in this study and shall include subjects meeting eligibility criteria classified as WHO Group 1 PAH or WHO Group 3 IPF-PH Subjects will receive inhaled nitric oxide from the GeNOsyl System to characterize the hemodynamic response and evaluate safety and tolerability
Dose cohorts of approximately 5 15 and 20 ppm nitric oxide in air will be studied Different dose levels will be achieved by varying the flow rate of the drug substance 80 ppm NO2 in balance air delivered to the subject via nasal cannula Each subject will receive two different doses of inhaled nitric oxide separated by a placebo medical grade air or supplemental oxygen washout Eligible subjects will be assigned to a dosing cohort in an escalating manner to receive study drug 80 ppm nitric oxide in air
Dose cohorts of approximately 5 15 and 20 ppm nitric oxide in air will be studied Different dose levels will be achieved by varying the flow rate of the drug substance 80 ppm NO2 in balance air delivered to the subject via nasal cannula Each subject will receive two different doses of inhaled nitric oxide separated by a placebo medical grade air or supplemental oxygen washout Eligible subjects will be assigned to a dosing cohort in an escalating manner to receive study drug 80 ppm nitric oxide in air
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHiano | OTHER | Study Sponsor GeNO LLC | None |