Actively Recruiting
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
Led by Octapharma · Updated on 2025-10-03
124
Participants Needed
22
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old (for first study phase) or at least 2 years old (for second study phase)
- Confirmed diagnosis of hereditary angioedema (HAE) type I or II
- At least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months; for ages 2 to 12, at least 1 moderate or severe attack in the last 6 months
- Documented congenital C1-INH functional activity less than 50% and C4 antigen level below normal
- Signed informed consent (and assent if applicable) by participant or legal representative
- Willingness to comply with all study procedures and available for the study duration
- If of childbearing potential, negative pregnancy test and use of highly effective contraception until 2 weeks after last dose
- Male participants must not plan to father a child or donate sperm for 90 days after last dose
You will not qualify if you...
- History of clinically relevant antibody development against C1-INH
- Medical history consistent with Type 3 HAE
- History of allergic reaction to C1-INH or other blood/plasma products
- History of unresolved B-cell malignancy in past 5 years
- Narcotic and/or alcoholic addiction
- Participation in another investigational drug study within 30 days before screening
- Pregnant or breastfeeding
- Clinically significant medical or psychiatric condition interfering with study participation
- History of thromboembolic events, myocardial infarction, unstable angina, critical aortic stenosis, stroke, severe peripheral vascular disease, or disseminated intravascular coagulation within 1 year before screening
- Clinically significant uncontrolled cardiovascular, pulmonary, or renal conditions until safety data review
- Recent use or planned use of certain medications or therapies (e.g., C1-INH products, hormone therapies, monoclonal antibodies, narcotic pain medications) before dosing
- Planned dental, medical, or surgical procedures during pharmacokinetic period requiring pre-procedural prevention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Octapharma Research Site
Centennial, Colorado, United States, 80112
Actively Recruiting
2
Octapharma Research Site
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
3
Octapharma Research Site
Toledo, Ohio, United States, 43617
Actively Recruiting
4
Octapharma Research Site
Tirana, Albania
Not Yet Recruiting
5
Octapharma Research Site
Rosario, Argentina
Not Yet Recruiting
6
Octapharma Research Site
Yerevan, Armenia
Actively Recruiting
7
Octapharma Research Site
Sofia, Bulgaria, 1431
Actively Recruiting
8
Octapharma Research Site
Lima, Mexico
Not Yet Recruiting
9
Octapharma Research Site
Mexico City, Mexico, 06720
Not Yet Recruiting
10
Octapharma Research Site
Podgorica, Montenegro
Not Yet Recruiting
11
Octapharma Research Site
Lima, Peru, 15001
Withdrawn
12
Octapharma Research Site
Lima, Peru, 15076
Not Yet Recruiting
13
Octapharma Research Site
Lima, Peru
Not Yet Recruiting
14
Octapharma Research Site
Cluj-Napoca, Romania, 400162
Actively Recruiting
15
Octapharma Research Site
Kragujevac, Serbia, 11221
Actively Recruiting
16
Octapharma Research Site
Ankara, Turkey (Türkiye)
Not Yet Recruiting
17
Octapharma Research Site
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
18
Octapharma Research Site
Izmir, Turkey (Türkiye)
Not Yet Recruiting
19
Octapharma Research Site
Sakarya, Turkey (Türkiye)
Not Yet Recruiting
20
Octapharma Research Site
Kyiv, Ukraine, 03057
Actively Recruiting
21
Octapharma Research Site
Lviv, Ukraine, 79010
Actively Recruiting
22
Octapharma Research Site
Lviv, Ukraine, 79035
Not Yet Recruiting
Research Team
P
Patrick M Murphy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here