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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT04416750
Date of registration: 28/05/2020
Prospective Registration: Yes
Primary sponsor: Imperial College London
Public title: Positioning Imatinib for Pulmonary Arterial Hypertension PIPAH
Scientific title: Positioning Imatinib for Pulmonary Arterial Hypertension
Date of first enrolment: January 20, 2021
Target sample size: 43
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04416750
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Name:     Andreas-Antonios Roussakis, MD, PhD
Address: 
Telephone: +44(0)2075946822
Email: a.roussakis@imperial.ac.uk
Affiliation: 
Name:     Martin R Wilkins, MD, FRCP
Address: 
Telephone:
Email:
Affiliation:  Imperial College London
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects aged between 18-75 years old

2. PAH which is idiopathic, heritable or associated with anorexigens

3. Subjects willing to be genotyped for genes that influence PDGF activity

4. Resting mean pulmonary artery pressure >25 mmHg, Pulmonary capillary wedge pressure
=15 mmHg, PVR >5 wood units, and normal or reduced cardiac output , as measured by
right heart catheterisation (RHC) at entry

5. Six-minute walking distance >50m at entry

6. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed
for PAH (any combination of endothelin receptor antagonist, phosphodiesterase
inhibitor or prostacyclin analogue) for at least 1 month prior to screening

7. Able to provide written informed consent prior to any study mandated procedures

8. Contraception: Fertile females (women of childbearing potential) are eligible to
participate after a negative highly sensitive pregnancy test, if they are taking a
highly effective method of contraception during treatment and until the end of
relevant systemic exposure. Fertile males who make use of condom and contraception
methods during treatment and until the end of relevant systemic exposure in women of
childbearing potential -full details are in included in the research protocol-

Exclusion criteria:

1. Unable to provide informed consent and/or are non-fluent speakers of the English
language

2. Hypersensitivity to Imatinib or to any of the excipients

3. Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per
1.73m2)

4. Clinically-significant liver disease (confirmed by serum transaminases >3 times than
upper normal limit)

5. Patients receiving oral and/or parenteral anticoagulants

6. Anaemia confirmed by haemoglobin concentration <10 g/dl

7. History of thrombocytopenia

8. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia

9. Hospital admission related to PAH or change in PAH therapy within 3 months prior to
screening

10. History of left-sided heart disease and/or clinically significant cardiac disease,
including but not limited to any of the following:

1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater
than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis,
moderate mitral regurgitation

2. Mechanical or bioprosthetic cardiac valve

3. Pericardial constriction, effusion with tamponade physiology, or abnormal left
atrial size.

4. Restrictive or congestive cardiomyopathy

5. Left ventricular ejection fraction =50% (measured in echocardiogram at screening)

6. Symptomatic coronary disease

7. Significant (2+ for regurgitation) valvular disease other than tricuspid or
pulmonary regurgitation

8. Acutely decompensated left heart failure within 1 month of screening

9. History of untreated obstructive sleep apnoea

11. Evidence of significant lung disease on high-resolution CT (if available) or recent
(performed within 12 months) lung function, where FEV1 < 50% predicted and FVC < 70%
predicted, and DLCO (or TLCO) < 50% predicted if any CT abnormalities; judged by the
Site Physician

12. Patients with a history of uncontrolled systemic hypertension

13. Acute infection (including eye, dental, and skin infections)

14. Chronic inflammatory disease including HIV, and Hepatitis B

15. Women of childbearing potential who are pregnant or breastfeeding (if applicable)

16. Previous intracerebral haemorrhage

17. Patients who have received an Investigational Medicinal Product (IMP) within 5
half-lives of the last dose of the IMP or 1 month (whichever is greater) before the
baseline visit



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pulmonary Arterial Hypertension
Intervention(s)
Drug: Imatinib Mesylate
Primary Outcome(s)
Change in pulmonary vascular resistance (PVR) [Time Frame: 24 months]
Identifying the highest tolerated dose [Time Frame: 12 months]
Secondary Outcome(s)
Change in brain natriuretic peptide (BNP) values [Time Frame: 24 weeks]
Change in ejection fraction measures [Time Frame: 24 weeks]
Change in exercise test [Time Frame: 24 weeks]
Change in quality of life scores [Time Frame: 24 weeks]
Secondary ID(s)
20/SC/0240
2020-001157-48
20HH5896
IRAS ID: 274093
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Medical Research Council
National Institute for Health Research, United Kingdom
University of Cambridge
University of Sheffield
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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