Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks

PHASE3RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Acute Hereditary Angio Edema
Interventions
DRUG

OCTA-C1-INH

OCTA-C1-INH is a stable, sterile, virus-inactivated, nano-filtered, highly purified concentrate of human C1-INH prepared from pooled human plasma. After reconstitution in 2.5mL water for injection, the solution can be administered as a slow IV injection. OCTA-C1-INH is given as a dose of 20 IU/kg body weight (BW)

OTHER

Placebo

0.1 mL/kg BW 0.9% sodium chloride injection

Trial Locations (22)

1431

RECRUITING

Octapharma Research Site, Sofia

11221

RECRUITING

Octapharma Research Site, Kragujevac

15001

WITHDRAWN

Octapharma Research Site, Lima

15076

NOT_YET_RECRUITING

Octapharma Research Site, Lima

43617

RECRUITING

Octapharma Research Site, Toledo

48334

RECRUITING

Octapharma Research Site, Farmington Hills

79010

RECRUITING

Octapharma Research Site, Lviv

79035

NOT_YET_RECRUITING

Octapharma Research Site, Lviv

80112

RECRUITING

Octapharma Research Site, Centennial

400162

RECRUITING

Octapharma Research Site, Cluj-Napoca

Unknown

NOT_YET_RECRUITING

Octapharma Research Site, Tirana

NOT_YET_RECRUITING

Octapharma Research Site, Rosario

RECRUITING

Octapharma Research Site, Yerevan

NOT_YET_RECRUITING

Octapharma Research Site, Lima

NOT_YET_RECRUITING

Octapharma Research Site, Podgorica

NOT_YET_RECRUITING

Octapharma Research Site, Lima

NOT_YET_RECRUITING

Octapharma Research Site, Ankara

NOT_YET_RECRUITING

Octapharma Research Site, Istanbul

NOT_YET_RECRUITING

Octapharma Research Site, Izmir

NOT_YET_RECRUITING

Octapharma Research Site, Sakarya

06720

NOT_YET_RECRUITING

Octapharma Research Site, Mexico City

03057

RECRUITING

Octapharma Research Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY