Drugs / C1-esterase inhibitor
C1-esterase inhibitor
also known as
Berinert · C1-INH · C1-inhibitor · HAEGARDA · C1-INH concentrate · C1-INH-R · CSL830 · pdC1-INH
Protein / enzyme biologic targets C1R, C1S via inhibition
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01759602 | Jan → Nov 2013 | neuromyelitis optica | Michael Levy | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02134314 | Sep 2014 → Mar 2017 | end stage renal failure, ischemic disease, kidney failure | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01576523 | Apr → Dec 2012 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 1/2 | NCT01134510 | Aug 2011 → Nov 2013 | — | Stanley Jordan, MD | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00168103 | Jun 2005 → Oct 2007 | hereditary angioedema | CSL Behring | Completed | Met primary |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT03221842 | Nov 2017 → Jan 2021 | transplant rejection | CSL Behring | Terminated | No outcome recorded |
| Phase 3 | NCT02584959 | Nov 2015 → Jul 2017 | hereditary angioedema | Shire | Completed | Met primary |
| Phase 3 | NCT02316353 | Dec 2014 → Sep 2017 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01912456 | Jan 2014 → Oct 2015 | hereditary angioedema | CSL Behring | Completed | Met primary |
| Phase 3 | NCT00292981 | Aug 2005 → Feb 2010 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03576469 | Jun 2018 → Dec 2019 | common variable immunodeficiency | IMMUNOe Research Centers | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT01766414 Comparator | Sep → Oct 2013 | infectious disease with sepsis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01275976 Comparator | Apr 2012 → Feb 2015 | infectious disease with sepsis, multiple organ dysfunction syndrome | UMC Utrecht | Terminated | No outcome recorded |
| Phase 3 | NCT00748202 Comparator | Sep 2008 → Dec 2010 | hereditary angioedema | Johann Wolfgang Goethe University Hospital | Completed | No outcome recorded |
| — | NCT00785018 Comparator | Nov → Dec 2008 | multiple organ dysfunction syndrome | Radboud University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 36 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | C1 Esterase Inhibitor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00168103 ↗ |
| Known as | Berinert | “The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH)...” PMID 21884533 ↗ Sep 20111“A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of...” NCT01576523 ↗ |
| Known as | C1-INH | “The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks” NCT02316353 ↗1“C1 inhibitor (C1-INH, Berinert) inhibits the classical and lectin pathways of C activation.” PMID 25606785 ↗ Feb 2015 |
| Known as | C1-INH concentrate | “The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH)...” PMID 21884533 ↗ Sep 2011 |
| Known as | C1-INH-R | “C1-esterase inhibitor [recombinant] (C1-INH-R)” NCT03576469 ↗ |
| Known as | C1-inhibitor | “Long-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE)” PMID 33588897 ↗ Feb 20211“C1 inhibitor (C1-INH, Berinert) inhibits the classical and lectin pathways of C activation.” PMID 25606785 ↗ Feb 2015 |
| Known as | CSL830 | “In a phase 2 trial, the use of CSL830, a nanofiltered C1 inhibitor preparation that is suitable for subcutaneous injection, resulted in functional levels of C1 inhibitor...” PMID 28328347 ↗ Mar 2017 |
| Known as | HAEGARDA | “Long-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE)” PMID 33588897 ↗ Feb 20211“a subcutaneous C1 inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) twice weekly significantly reduced the frequency of acute edema attacks.” PMID 31485239 ↗ Aug 2019 |
| Known as | pdC1-INH | “Long-term prophylaxis with twice-weekly intravenous injections of plasma-derived C1-inhibitor (pdC1-INH) has been established as an effective treatment.” PMID 26016741 ↗ Aug 2015 |
| Action | Restore | “Placebo-controlled studies established the efficacy of replacement therapy with C1 esterase inhibitor (C1-INH) concentrate for treating single acute hereditary angioedema (HAE) attacks” PMID 22856636 ↗ Jul 2012 |
| Modality | Protein / enzyme biologic | “Human Pasteurized C1 Esterase Inhibitor Concentrate” NCT00292981 ↗ |
| Route | Intravenous | “C1-INH administered intravenously by slow injection or infusion” NCT00168103 ↗ |
| Target | C1R | “although C1r and C1s are targets of C1-inh” PMID 25191939 ↗ Sep 2014 |
| Target | C1S | “although C1r and C1s are targets of C1-inh” PMID 25191939 ↗ Sep 2014 |