Status:
TERMINATED
Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary e...
Eligibility Criteria
Inclusion
- Age \>18 years
- Diagnosis of PAH (from prior right heart catheterization), with functional class III symptoms of right ventricle failure despite optimal PAH therapy
- Mean pulmonary artery pressure \>25 mmHg
- Pulmonary capillary wedge pressure \<15 mmHg
- Pulmonary vascular resistance \>3 wood units
Exclusion
- PAH due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity \<65% predicted value), or cirrhosis (portopulmonary hypertension)
- Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
- Recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
- Severe kidney dysfunction (eGFR \<30 mL/min)
- Thrombocytopenia (\<50,000/mm3), or neutropenia (absolute neutrophil count \<1,500/mm3)
- Refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (IUD), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study
- History of hypersensitivity to anakinra or E. coli products
- Latex or rubber allergy
- Inability to give informed consent
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01479010
Start Date
November 1 2011
End Date
November 1 2013
Last Update
November 13 2017
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298