Status:
TERMINATED
Olaparib for PAH: a Pilot Study
Lead Sponsor:
Laval University
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The main OBJECTIVE of this proposal is to extend our preclinical findings on the role of DNA damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating disease, pulmonary...
Detailed Description
BACKGROUND PAH is a progressive and multifactorial condition characterized by the chronic elevation of pulmonary artery (PA) pressure leading to RV failure. In spite of currently approved therapies, p...
Eligibility Criteria
Inclusion
- 1\) adults (18-75 yrs) with PAH of idiopathic/ hereditary/drug or toxin-induced origin or associated with connective tissue diseases; 2) mean PA pressure ≥25mmHg, PA wedge pressure ≤15mmHg, PVR \>480 dyn.s.cm-5 and absence of acute vasoreactivity (we expect PARP1 inhibition will be most effective in patients with significant PA remodelling); 3) WHO functional class II or III; 4) clinically stable with unchanged vasoactive therapy for ≥4 months; 5) two 6MWD of 150-550m and within ±15% of each other (the latter being used as baseline value); 6) a negative serum pregnancy test prior to receiving the first dose of study treatment and willing to use adequate contraception from enrolment through 3 months after the last dose of study treatment for patients of childbearing potential
Exclusion
- 1\) other types of pulmonary hypertension; 2) significant restrictive (total lung capacity \<60% predicted) or obstructive (FEV1/FVC\<60% after a bronchodilator) lung disease; 3) systolic blood pressure \<90 mmHg; 4) acute RV failure within the last 3 months; 5) received any investigational drug within 30 days; 6) BMI \<18 or \>40 kg/m2; 7) cardiopulmonary rehabilitation program planned or started ≤12 weeks prior to Day 1; 8) presence of ≥3 risk factors for heart failure with preserved ejection fraction (BMI \>30 kg/m2, diabetes mellitus, hypertension or coronary artery disease); 9) organ dysfunction other than RV failure; 10) anticipated survival \<1 year due to concomitant disease
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03251872
Start Date
October 25 2018
End Date
December 1 2019
Last Update
August 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IUCPQ-UL
Québec, Quebec, Canada, G1V 4G5