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Clinical Trial Summary

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. Lanadelumab, also known as TAK-743, is a medicine to help prevent angioedema attacks. This expanded access program enables these participants with a high unmet medical need to continue receiving lanadelumab during the interim period between completion of either the SHP643-301 (NCT04070326; SPRING study) or the TAK-743-3001 (NCT04444895) study and potential licensure of lanadelumab for the respective age group and/or treatment.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04583007
Study type Expanded Access
Source Takeda
Contact
Status No longer available
Phase

See also
  Status Clinical Trial Phase
Completed NCT02865720 - Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) Phase 3
Completed NCT04861090 - A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
Recruiting NCT05489640 - A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
Completed NCT02584959 - Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT01826916 - EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema Phase 2
Completed NCT04057131 - FIRAZYR General Drug Use-Results Survey (Japan)
Recruiting NCT05819775 - CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema Phase 3
Recruiting NCT05397431 - A Survey of Lanadelumab in Participants With Hereditary Angioedema
Completed NCT02741596 - Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02093923 - A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants Phase 1
Completed NCT01541423 - A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
Completed NCT03845400 - A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Completed NCT02586805 - Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02052141 - Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema Phase 3
Completed NCT03888755 - A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants Phase 3
Recruiting NCT05147181 - A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
Recruiting NCT05469789 - A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
Completed NCT05460325 - A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) Phase 3
Completed NCT01095510 - CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 Phase 2
Recruiting NCT05578417 - A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada