C1 esterase inhibitor (C1-INH) - Standard of Care for the Treatment of Acute Attacks in Hereditary Angioedema (HAE): Initial Results of an Ongoing, Prospective, Open Label Study in North America (I.M.P.A.C.T.2)

2008 ◽  
Vol 121 (2) ◽  
pp. S98-S99 ◽  
Author(s):  
T CRAIG ◽  
R WASSERMANN ◽  
R LEVY ◽  
A BEWTRA ◽  
D HUREWITZ ◽  
...  
Keyword(s):  
North America ◽  
Hereditary Angioedema ◽  
Standard Of Care ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
C1 Esterase Inhibitor ◽  
Acute Attacks ◽  
Initial Results ◽  
Esterase Inhibitor

Nanofiltered C1 esterase inhibitor (human) for the treatment of acute attacks of hereditary angioedema: an open-label trial

2012 ◽  
Vol 108 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Marc A. Riedl ◽  
David S. Hurewitz ◽  
Robyn Levy ◽  
Paula J. Busse ◽  
David Fitts ◽  
...  
Keyword(s):  
Hereditary Angioedema ◽  
Open Label ◽  
C1 Esterase Inhibitor ◽  
Open Label Trial ◽  
Acute Attacks ◽  
Esterase Inhibitor

scholarly journals Prospective, Randomized, Parallel-Group, Open-Label Study to Evaluate the Efficacy and Safety of IMU-838, in Combination with Oseltamivir, in Adults with Coronavirus Disease 19 The IONIC Trial

2021 ◽  
Author(s):  
Kavi Sharma ◽  
Dr Lisa Berry ◽  
Dr Evangelos Vryonis ◽  
Dr Asad Ali ◽  
Dr Beatriz Lara ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Trial Design ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Therapeutic Effects ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Link Type ◽  
Discharge From Hospital

Background: Globally there is a scarcity of effective treatments for SARS-CoV-2 infections (causing COVID 19). Repurposing existing medications may offer the best hope for treating COVID 19 patients to curb the pandemic. IMU-838 is a dihydroorotate dehydrogenase (DHODH) inhibitor, which is an effective mechanism for antiviral effects against respiratory viruses. When used synergistically with Oseltamivir, therapeutic effects have been observed against influenza and SARS-CoV-2 in rodents.(13) The IONIC trial is a randomized control trial that will investigate whether time to clinical improvement in COVID 19 patients is improved following a 14 day course of IMU-838 + Oseltamivir versus Oseltamivir alone. Methods: IONIC trial is an open label study in which participants will be randomised 1:1 in two parallel arms; the intervention arm (IMU-838 + Oseltamivir) and control arm (Oseltamivir only). The primary outcome is time-to-clinical improvement; defined as the time from randomisation to: a 2-point improvement on WHO ordinal scale; discharge from hospital, or death (whichever occurs first). The study is sponsored by UHCW NHS Trust and funded by LifeArc. Discussion: The IONIC Protocol describes an overarching trial design to provide reliable evidence on the efficacy of IMU-838 (vidofludimus calcium) when delivered in combination with an antiviral therapy (Oseltamivir) [IONIC Intervention] for confirmed or suspected COVID-19 infection in adult patients receiving usual standard of care. Trial Registration: The trial was registered with EudraCT (2020-001805-21) on 09.04.2020 and ISRCTN on 23.09.2020 (ISRCTN53038326) and Clinicaltrials.gov on 17.08.2020 (NCT04516915) Strengths and Limitations: This study is the first to recruit participants in the trial exploring the effectiveness of IMU-838 in COVID-19. In addition, we believe it is the only trial exploring the effectiveness of IMU-838 in combination with Oseltamivir (Tamiflu) in patients with moderate to severe COVID-19. However, to make the trial design flexible due to the on-going pandemic the trial is un-blinded.

scholarly journals Efficacy, pharmacokinetics, and safety of icatibant for the treatment of Japanese patients with an acute attack of hereditary angioedema: A phase 3 open-label study

2020 ◽  
Vol 69 (2) ◽  
pp. 268-273 ◽  
Author(s):  
Michihiro Hide ◽  
Atsushi Fukunaga ◽  
Junichi Maehara ◽  
Kazunori Eto ◽  
James Hao ◽  
...  
Keyword(s):  
Hereditary Angioedema ◽  
Japanese Patients ◽  
Acute Attack ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study
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