Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension
Intervention: Anakinra 100 mg subcutaneously daily (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): Benjamin Van Tassell, Pharm D., Principal Investigator, Affiliation: Virginia Commonwealth University
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 exercise testing at baseline, and after 4 weeks treatment with
Anakinra (recombinant human Interleukin-1 receptor antagonist.
Clinical Details
Official title: Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Median Interval Change From Baseline in Peak VO2Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)
Secondary outcome: Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2 Rate of Adverse Events and Hospitalizations Total Exercise Time Oxygen Uptake Efficiency Slope
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: November 2011
Last updated: May 20, 2015
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