Pericarditis - ClinicalTrials.gov

Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study

Patients with recurrent pericarditis will be scrutinized and informed consent will be obtained. The following reviews include clinical evaluation, including vital signs, and the highest NRS pain score within the first 7 days of Day 1, 12-lead ECG; C-SSRS, hematology and blood chemistry, and a pregnancy questionnaire for women with childbearing potential. If the next higher dose after each study drug increase is not accepted, the dosage will be reduced to the previous tolerated dose. This involves extensive ECG monitoring at just 5 hours post-morning dose to avert deleterious effects on ECG intervals and rhythm. The determination of drug titration will be dependent on investigator interrogation of the ECGs and the absence of abnormalities on those ECGs.

Source link: https://clinicaltrials.gov/ct2/show/NCT05494788

Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis

Participants with pericarditis recurrence who meet the protocol for bailout rilonacept receive bailout rilonacept regardless of randomized treatment scheme, and as soon as at least five days have passed since the last study drug injection. Participants who are still in the RI period at the time that the RW has concluded and the LTE has opened will have the ability to join the LTE directly when they have completed the RI period and have met the criteria of clinical response or withdrawal from the study.

Source link: https://clinicaltrials.gov/ct2/show/NCT03737110

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