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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 VO2

Median 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

Page last updated: August 23, 2015

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