Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide
Information source: Geno LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: Inhaled Nitric Oxide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Geno LLC Official(s) and/or principal investigator(s):
Cassie Newell, MAOM, Study Director, Affiliation: Geno LLC
Overall contact:
Robert Roscigno, PhD, Email: Robert.Roscigno@genollc.com
Summary
The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of
GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation
predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health
Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically
necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo
an attempt to wean from parenteral PGI per standard of care.
Clinical Details
Official title: A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Wean Success vs Wean Failure
Detailed description:
This study will be divided into 2 parts: a Pilot Phase followed by Pivotal Phase.
- The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot
Phase will evaluate safety, and assess the vasoreactivity test response rate.
- Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to
gather further data on weaned successes from parenteral PGI. The Investigator and
study staff involved with the wean and patient management will be blinded in this phase
of the study to the vasoreactivity results.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject or subject's legally authorized representative signs and dates an
Institutional Review Board (IRB) approved informed consent form prior to the
initiation of any study-related activities.
- The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I
or II at Screening.
- The subject has documented continuous PGI use for ≥ 1 year from Screening, without a
significant interruption (i. e., ≤ 2 day interruption) and without a failed complete
wean attempt.
- The subject is a candidate for weaning off parenteral PGI therapy (per Investigator
judgment and standard of care).
Exclusion Criteria
- The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide
or other clinically significant allergies (clinical significance per Investigator
judgment).
- The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at
Baseline.
- The subject has participated in an investigational product or device study within the
30 days prior to Screening.
Locations and Contacts
Robert Roscigno, PhD, Email: Robert.Roscigno@genollc.com
University of Alabama, Birmingham, Alabama 35294, United States; Recruiting
Leigh Powell, RN, Email: Leigh83@uab.edu
Jose Tallaj, MD, Principal Investigator
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Joan Rossi, RN, Email: jrossi1@wpahs.org
Raymond Benza, MD, Principal Investigator
Additional Information
Starting date: June 2015
Last updated: June 29, 2015
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