hereditary angioedema
Information
- Disease name
- hereditary angioedema
- Disease ID
- DOID:14735
- Description
- "An angioedema that is characterized by recurrent episodes of severe swelling of the skin and mucous membranes." [url:https\://medlineplus.gov/genetics/condition/hereditary-angioedema/]
Disease area statistics
[No Data.]
Chromosome band
[No Data.]
Annotation
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT05121376 | Active, not recruiting | Phase 1/Phase 2 | A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema | February 15, 2022 | November 2028 |
| NCT04739059 | Active, not recruiting | Phase 3 | Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks | March 29, 2021 | November 2025 |
| NCT04307381 | Active, not recruiting | Phase 2 | An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema | April 1, 2020 | April 2025 |
| NCT05453968 | Active, not recruiting | Phase 3 | Berotralstat Treatment in Children With Hereditary Angioedema | October 25, 2022 | July 2027 |
| NCT05120830 | Active, not recruiting | Phase 1/Phase 2 | NTLA-2002 in Adults With Hereditary Angioedema (HAE) | December 10, 2021 | March 31, 2026 |
| NCT04933721 | Active, not recruiting | Phase 3 | Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies | July 23, 2021 | August 2026 |
| NCT05047185 | Active, not recruiting | Phase 2 | Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II | April 19, 2022 | December 2026 |
| NCT04428632 | Approved for marketing | Oral Berotralstat Expanded Access Program | |||
| NCT06415448 | Available | Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema | |||
| NCT00748202 | Completed | Phase 3 | Berinert P Study of Subcutaneous Versus Intravenous Administration | September 2008 | December 2010 |
| NCT00851409 | Completed | Phase 2 | A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration | June 2009 | April 2010 |
| NCT00912093 | Completed | Phase 3 | A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) | July 16, 2009 | October 1, 2010 |
| NCT00914966 | Completed | Phase 4 | A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE | August 31, 2009 | May 24, 2012 |
| NCT00997204 | Completed | Phase 3 | EASSI - Evaluation of the Safety of Self-Administration With Icatibant | September 25, 2009 | June 22, 2011 |
| NCT01005888 | Completed | Phase 3 | C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks | March 14, 2005 | August 22, 2007 |
| NCT01095497 | Completed | Phase 2 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration | June 7, 2010 | December 16, 2010 |
| NCT01188564 | Completed | Phase 3 | Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks | January 2011 | March 2013 |
| NCT01359969 | Completed | Phase 2 | Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients | January 17, 2012 | July 17, 2017 |
| NCT01426763 | Completed | Phase 2 | A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase | September 12, 2011 | November 28, 2011 |
| NCT01457430 | Completed | Phase 4 | Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE | December 2011 | April 2014 |
| NCT01679912 | Completed | Phase 4 | A Call Center During HAE Attacks (SOS HAE) | March 2013 | September 2016 |
| NCT01984788 | Completed | Phase 2 | Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE | November 2013 | May 2014 |
| NCT02125162 | Completed | Phase 1 | A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161 | April 2014 | July 2014 |
| NCT02218294 | Completed | Phase 1 | Study to Determine How BCX4161 is Metabolized and Eliminated by the Body | August 2014 | September 2014 |
| NCT02247739 | Completed | Phase 2 | A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor | December 2014 | September 2016 |
| NCT02303626 | Completed | Phase 2/Phase 3 | 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks | November 2014 | January 2016 |
| NCT02448264 | Completed | Phase 1 | First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers | May 2015 | December 2015 |
| NCT02819102 | Completed | Phase 1 | An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates | March 2016 | June 2016 |
| NCT03029728 | Completed | Biomarker for Hereditary AngioEdema Disease | August 20, 2018 | March 11, 2022 | |
| NCT03136237 | Completed | Phase 1 | A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions | February 17, 2017 | August 15, 2017 |
| NCT03202784 | Completed | Phase 1 | A Relative Bioavailability Study of Two Formulations of BCX7353 | February 27, 2017 | September 30, 2017 |
| NCT03472040 | Completed | Phase 2/Phase 3 | A Long Term Safety Study of BCX7353 in Hereditary Angioedema | February 16, 2018 | April 27, 2022 |
| NCT03485911 | Completed | Phase 3 | Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE | February 6, 2018 | April 6, 2022 |
| NCT03697187 | Completed | Patient Registry to Evaluate the Real-world Safety of Ruconest® | June 30, 2018 | July 31, 2021 | |
| NCT03712228 | Completed | Phase 2 | A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) | October 29, 2018 | October 15, 2021 |
| NCT04030598 | Completed | Phase 2 | A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema | January 7, 2020 | March 1, 2021 |
| NCT04070326 | Completed | Phase 3 | A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children | August 19, 2019 | October 30, 2021 |
| NCT04208412 | Completed | Phase 2 | A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II | July 2, 2019 | December 8, 2020 |
| NCT04349800 | Completed | Phase 1 | A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 in Healthy Volunteers | January 4, 2018 | September 10, 2018 |
| NCT04557319 | Completed | Phase 1 | Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers | March 10, 2020 | August 27, 2020 |
| NCT00168103 | Completed | Phase 2/Phase 3 | Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks | June 2005 | December 2007 |
| NCT04654351 | Completed | Phase 3 | A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema | January 15, 2021 | July 27, 2021 |
| NCT04656418 | Completed | Phase 3 | CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks | January 27, 2021 | June 7, 2022 |
| NCT04687137 | Completed | Phase 3 | Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema | February 10, 2021 | June 18, 2022 |
| NCT04888650 | Completed | Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema | May 3, 2021 | January 2, 2022 | |
| NCT04618211 | Completed | Phase 2 | Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema | February 3, 2021 | March 1, 2023 |
| NCT00225147 | Completed | Phase 2/Phase 3 | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | July 2005 | January 2010 |
| NCT00262301 | Completed | Phase 3 | Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema | June 2004 | October 2009 |
| NCT00289211 | Completed | Phase 3 | C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks | March 14, 2005 | April 13, 2007 |
| NCT00292981 | Completed | Phase 3 | C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study) | August 2005 | May 2010 |
| NCT00432510 | Completed | Phase 1 | Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects | October 9, 2006 | February 28, 2007 |
| NCT00438815 | Completed | Phase 3 | Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks | September 21, 2006 | March 31, 2009 |
| NCT00462709 | Completed | Phase 3 | Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks | June 27, 2006 | March 31, 2009 |
| NCT00500656 | Completed | Phase 3 | Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) | March 1, 2005 | July 25, 2006 |
| NCT04957641 | Completed | A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema | April 21, 2022 | January 13, 2023 | |
| NCT05118958 | Completed | Phase 1 | Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations | May 19, 2020 | December 1, 2020 |
| NCT05139810 | Completed | Phase 3 | OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE) | December 3, 2021 | November 9, 2023 |
| NCT05178355 | Completed | Phase 1 | A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers | February 12, 2019 | June 21, 2019 |
| NCT05259917 | Completed | Phase 3 | A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) | February 23, 2022 | December 31, 2023 |
| NCT05477160 | Completed | Phase 1 | A Study of STAR-0215 in Healthy Adult Participants | July 27, 2022 | November 17, 2023 |
| NCT06408805 | Completed | Autonomic Nervous System Profile in Hereditary Angioedema | July 12, 2023 | March 18, 2024 | |
| NCT06414252 | Completed | Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients | May 15, 2023 | March 18, 2024 | |
| NCT06262399 | Enrolling by invitation | Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 | April 12, 2024 | April 2040 | |
| NCT06007677 | Enrolling by invitation | Phase 2 | A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema | September 26, 2023 | August 2030 |
| NCT05392114 | Recruiting | Phase 3 | A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) | July 13, 2022 | March 2027 |
| NCT05396105 | Recruiting | Phase 2/Phase 3 | Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema | December 28, 2022 | December 2024 |
| NCT01397864 | Recruiting | C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks | July 2011 | January 2025 | |
| NCT05505916 | Recruiting | Phase 3 | An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) | October 24, 2022 | January 30, 2026 |
| NCT05511922 | Recruiting | Phase 3 | PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial | October 24, 2022 | January 30, 2026 |
| NCT05691361 | Recruiting | Phase 1 | Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients | December 14, 2022 | December 26, 2025 |
| NCT05695248 | Recruiting | Phase 1/Phase 2 | A Study of STAR-0215 in Participants With Hereditary Angioedema | February 21, 2023 | September 2025 |
| NCT06343779 | Recruiting | Phase 3 | Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema | February 26, 2024 | March 2026 |
| NCT02670720 | Terminated | Phase 3 | Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema | December 2015 | February 2016 |
| NCT02854397 | Terminated | Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population | February 15, 2016 | June 2020 | |
| NCT04091113 | Terminated | Hereditary Angioedema Kininogen Assay | September 1, 2019 | December 31, 2021 | |
| NCT02159430 | Unknown status | Hereditary AngioEdema, Neurobiology and Psychopathology | November 2014 | May 2015 | |
| NCT01151735 | Withdrawn | Phase 4 | C1-INH Compared to Placebo at the Time of Prodromal Symptoms for Hereditary Angioedema (HAE) Exacerbation | July 2010 | July 2012 |
| NCT04898309 | Withdrawn | Phase 2/Phase 3 | Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema | December 1, 2021 | May 31, 2023 |
- Disase is a (Disease Ontology)
- DOID:1558
- Cross Reference ID (Disease Ontology)
- GARD:5979
- Cross Reference ID (Disease Ontology)
- MESH:D054179
- Cross Reference ID (Disease Ontology)
- MIM:PS106100
- Cross Reference ID (Disease Ontology)
- NCI:C84758
- Cross Reference ID (Disease Ontology)
- ORDO:91378
- Cross Reference ID (Disease Ontology)
- SNOMEDCT_US_2023_03_01:82966003
- Cross Reference ID (Disease Ontology)
- UMLS_CUI:C0019243
- Exact Synonym (Disease Ontology)
- HANE
- Exact Synonym (Disease Ontology)
- Hereditary angioneurotic edema
- OrphaNumber from OrphaNet (Orphanet)
- 91378