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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01479010
Other study ID # HM13729
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received November 7, 2011
Last updated October 9, 2017
Start date November 2011
Est. completion date November 2013

Study information

Verified date October 2017
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Anakinra 100 mg subcutaneously daily
Anakinra 100 mg subcutaneously daily

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median Interval Change From Baseline in Peak VO2 Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask. 28 days
Primary Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask. 28 days
Secondary Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide) 28 days
Secondary Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) 28 days
Secondary Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2 28 days
Secondary Rate of Adverse Events and Hospitalizations 28 days
Secondary Total Exercise Time 28 days
Secondary Oxygen Uptake Efficiency Slope 28 days
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