Hereditary Angioedema
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CLINICAL_TRIALS trial_result · 2011-06-23Clinical Trial Update: C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study) [Phase 3]
A Phase 3 extension study of a C1 esterase inhibitor for hereditary angioedema has completed, with results posted in 2011.
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FDA approval · 2011-04-05FDA Approved: KALBITOR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Kalbitor (ecallantide) from Takeda Pharmaceuticals America, Inc. Kalbitor treats hereditary …
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CLINICAL_TRIALS trial_result · 2011-01-19Clinical Trial Update: Berinert P Study of Subcutaneous Versus Intravenous Administration [Phase 3]
Phase 3 clinical trial comparing subcutaneous versus intravenous administration of Berinert P for hereditary angioedema has completed.
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CLINICAL_TRIALS trial_result · 2010-08-24Clinical Trial Update: Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks [Phase 2, Phase 3]
This clinical trial update reports the completion and results posting of Phase 2 and Phase 3 trials evaluating human C1 esterase inhibitor (…
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CLINICAL_TRIALS trial_result · 2010-06-09Clinical Trial Update: Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks [Phase 3]
Phase 3 open-label trial of C1 esterase inhibitor (C1INH-nf) for acute hereditary angioedema attacks completed with results posted in 2010.
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CLINICAL_TRIALS trial_result · 2010-06-03Clinical Trial Update: C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks [Phase 3]
Phase 3 trial evaluating C1 esterase inhibitor for prevention of acute attacks in hereditary angioedema has completed with results posted in…
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CLINICAL_TRIALS trial_result · 2010-06-02Clinical Trial Update: C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks [Phase 3]
Phase 3 trial update for C1 Esterase Inhibitor (C1INH-nf) in acute hereditary angioedema attacks has completed with posted results.
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CLINICAL_TRIALS trial_result · 2010-05-11Clinical Trial Update: Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE) [Phase 3]
Phase 3 trial update for DX-88 evaluating efficacy and safety in treating acute attacks of hereditary angioedema (HAE) has completed with re…
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CLINICAL_TRIALS trial_result · 2010-05-04Clinical Trial Update: Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE) [Phase 3]
Phase 3 trial evaluating DX-88 (ecallantide) for acute attacks of hereditary angioedema has completed with results posted in 2010.
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CLINICAL_TRIALS trial_result · 2010-05-03Clinical Trial Update: Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks [Phase 3]
Phase 3 open-label trial evaluating C1 esterase inhibitor (C1INH-nf) for prevention of acute attacks in hereditary angioedema completed with…
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FDA approval · 2009-12-01FDA Approved: KALBITOR — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved Kalbitor (ecallantide) through an Original Application, confirming its approval for treatment of hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2009-05-04Clinical Trial Update: Kinetics, Efficacy and Safety of C1-Esteraseremmer-N [Phase 2]
Phase 2 trial results for C1-Esteraseremmer-N assess kinetics, efficacy, and safety in hereditary angioedema. The study is reported as compl…
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CLINICAL_TRIALS trial_result · 2009-05-04Clinical Trial Update: C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema [Phase 3]
Phase 3 clinical trial update for C1-Esteraseremmer-N in hereditary and acquired angioedema; the study has completed.
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CLINICAL_TRIALS trial_result · 2009-05-04Clinical Trial Update: C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema [Phase 2, Phase 3]
Clinical trial update indicating completion of Phase 2 and Phase 3 studies of C1-Esteraseremmer-N for hereditary and acquired angioedema, sp…
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FDA approval · 2007-04-19FDA Approved: DANAZOL — Original Application (Lannett Company, Inc.)
FDA approved the original application for the generic Danazol (DANAZOL) from Lannett Company, Inc. Indications include endometriosis, heredi…