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NCT01479010 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Virginia Commonwealth University.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT01479010: Clinical Trial Phase 1 study, sponsored by Virginia Commonwealth University.

NCT01479010 is a Phase 1 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01479010, a Phase 1 study, was terminated before completion, sponsored by Virginia Commonwealth University.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study 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.

Primary Outcome

Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.

Interventions

  • DRUG Anakinra 100 mg subcutaneously daily

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2011-11
Est. Completion 2013-11
Phase Phase 1
Virginia Commonwealth University

558 total trials

Why NCT01479010 stopped before completion

NCT01479010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Anakinra 100 mg subcutaneously daily is the first listed.

NCT01479010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01479010 about?

NCT01479010 is a clinical study titled "Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension". 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 Interleuki...

What is the current status of trial NCT01479010?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2011-11. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01479010?

The interventions under investigation include: Anakinra 100 mg subcutaneously daily (DRUG).

Who is sponsoring clinical trial NCT01479010?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01479010's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01479010, the US trial registry maintained by the National Library of Medicine. NCT01479010 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.