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

Conditions

• Acute Hereditary Angio Edema

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OCTA-C1-INH — DRUG
  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)
• Placebo — OTHER
  0.1 mL/kg BW 0.9% sodium chloride injection

Study Details

Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks

Key Dates

Start date

Apr 30, 2024

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: OCTA-C1-INH
  OCTA-C1-INH injection, 20IU/kg BW after first qualifying attack. Treatment to be administered to blinded as well as open-label subjects.
• Placebo Comparator: Placebo
  0.1 mL/kg BW 0.9% sodium chloride solution injection after first qualifying attack. Only blinded subjects to receive.

Primary Outcome Measure

Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants. [ Time Frame: Within 4 hours after injection ]

Central Contacts

• Patrick M Murphy
  8663371868
  [email protected]

Locations (3)

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