C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Shire

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

Documented HAE

Normal C1q level

Relatively frequent angioedema attacks (at least 2 per month on average)

Treatment Details

Interventions

C1INH-nf (C1 Esterase Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Placebo First, then C1INH-nfExperimental Treatment2 Interventions

Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.

Group II: C1INH-nf First, then PlaceboExperimental Treatment2 Interventions

1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.