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C1 Esterase Inhibitor
IV C1 Esterase Inhibitor for Hereditary Angioedema
Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has confirmed diagnosis of HAE type I or II
Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 hours after injection
Awards & highlights
Pivotal Trial
Summary
This trial is a study testing the effectiveness and safety of a new treatment for people with a genetic condition called hereditary angioedema. The treatment is given through an IV and aims to prevent and
Who is the study for?
This trial is for individuals with a confirmed diagnosis of Hereditary Angioedema (HAE) types I or II. Participants must have had multiple HAE attacks in recent months and have specific levels of C1-INH activity and C4 antigen. They should agree to follow study procedures, use certain contraceptives if applicable, and be at least 18 years old for phase one or at least 2 years old for phase two.
What is being tested?
The trial is testing an intravenous treatment called OCTA-C1-INH against a placebo to see if it's effective and safe in treating acute hereditary angioedema attacks. It's a phase 3 study where participants are randomly assigned to receive either the real medication or a placebo in different groups without knowing which they're getting.
What are the potential side effects?
While the document does not specify side effects, treatments like OCTA-C1-INH could potentially cause reactions at the infusion site, allergic responses, headaches, nausea, or changes in blood pressure due to its nature as an enzyme inhibitor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with HAE type I or II.
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I've had 3 or more severe HAE attacks in the last 3 months, or if I'm between 2-12 years old, at least 1 in the last 6 months.
Select...
My test shows low C1-INH activity and C4 levels.
Select...
I use progesterone-only birth control that stops ovulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 4 hours after injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 hours after injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants.
Secondary study objectives
Changes in symptom severity at the defining site by VAS severity rating
Percentage of participants responding to treatment
Time to beginning of unequivocal symptom relief at all sites involved
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OCTA-C1-INHExperimental Treatment1 Intervention
OCTA-C1-INH injection, 20IU/kg BW after first qualifying attack. Treatment to be administered to blinded as well as open-label subjects.
Group II: PlaceboPlacebo Group1 Intervention
0.1 mL/kg BW 0.9% sodium chloride solution injection after first qualifying attack. Only blinded subjects to receive.
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Who is running the clinical trial?
OctapharmaLead Sponsor
85 Previous Clinical Trials
11,133 Total Patients Enrolled
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