Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Status Completed

Clinical Trial Summary

This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03240133
Study type	Interventional
Source	BioCryst Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	July 31, 2017
Completion date	January 29, 2019

View Details

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