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Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension

NCT ID: NCT01479010

Last Updated: 2017-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anakinra

Group Type EXPERIMENTAL

Anakinra 100 mg subcutaneously daily

Intervention Type DRUG

Anakinra 100 mg subcutaneously daily

Interventions

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Anakinra 100 mg subcutaneously daily

Anakinra 100 mg subcutaneously daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Van Tassell, Pharm D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM13729

Identifier Type: -

Identifier Source: org_study_id