BridgeMD
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
EU CTIS ID: 2023-503507-29-00
What this study is testing
To confirm the superiority of OCTA-C1-INH in comparison to placebo administered in a double-blind manner by slow IV injection to relieve symptoms of an acute attack in adult and adolescent participants (≥12 to <18 years of age) with HAE.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)
- 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
- Has a documented congenital C1-INH functional activity <50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range
- Participant or the participant’s legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable
- States willingness to comply with all study procedures and availability for the duration of the study
You likely can't join if
- Has a history of clinically relevant antibody development against C1-INH
- (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml/min per 1.73 m2)
- Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 years, no family history, no known HAE mutation, low C1q level in plasma)
- Has a history of allergic reaction to C1-INH or other blood/plasma product
- Has a history of B-cell malignancy that was unresolved in the past 5 years
- Has a narcotic and/or alcoholic addiction
See the full eligibility criteria
- Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)
- 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
- Has a documented congenital C1-INH functional activity <50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range
- Participant or the participant’s legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable
- States willingness to comply with all study procedures and availability for the duration of the study
- If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause)
- Has a history of clinically relevant antibody development against C1-INH
- (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml/min per 1.73 m2)
- Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 years, no family history, no known HAE mutation, low C1q level in plasma)
- Has a history of allergic reaction to C1-INH or other blood/plasma product
- Has a history of B-cell malignancy that was unresolved in the past 5 years
- Has a narcotic and/or alcoholic addiction
- Has participated in any other investigational drug evaluation within 30 days before screening
- Is pregnant or breastfeeding
- Has any clinically significant medical or psychiatric condition that, in the investigator’s opinion would interfere with the participant’s ability to participate in the study
- Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- India
- Kazakhstan
- Montenegro
- Argentina
- Armenia
- Albania
- Serbia
- Mexico
- Ukraine
- United States
- Peru
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; India; Kazakhstan; Montenegro; Argentina; Armenia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.