Trial Outcomes & Findings for Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension (NCT NCT01479010)
NCT ID: NCT01479010
Last Updated: 2017-11-13
Results Overview
Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.
TERMINATED
PHASE1/PHASE2
2 participants
28 days
2017-11-13
Participant Flow
Participant milestones
| Measure |
Anakinra
Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Due to the small number of participants, results are not included to protect the privacy of individual participants.
Outcome measures
Outcome data not reported
Adverse Events
Anakinra
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anakinra
n=2 participants at risk
Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
50.0%
1/2 • Number of events 1
|
Additional Information
Benjamin Van Tassell, PharmD
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place