Phase 2
Completed N=32
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
Source: ClinicalTrials.gov NCT02247739 ↗Enrolled (actual)
32
Serious AEs
1.2%
Results posted
Dec 2017
Primary outcomePrimary: Number of HAE Attacks — 2.74; 4.36; 7.18 attacks
Summary
Primary Objective:
To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Secondary Objective:
To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of HAE Attacks |
2.74; 4.36; 7.18 | — |
| SECONDARY Number of Participants With Adverse Events |
10; 13; 8 | — |
| SECONDARY Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks |
74; 42 | — |
Eligibility Criteria
Inclusion Criteria
Patients fulfilling the following criteria at Screening are eligible for participation in the study:
- Age 13 years or older
- Laboratory confirmed diagnosis of HAE
- A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months).
- Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception.
- Provided written informed consent (and written assent for minors)
- Willingness and ability to comply with all protocol procedures
Exclusion Criteria
Patients who meet any of the following criteria at Screening are to be excluded from study participation:
- Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
- Diagnosis of acquired angioedema (AAE)
- Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant
- Treatment with any investigational drug in the past 30 days
- Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
- Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
Data sourced from ClinicalTrials.gov (NCT02247739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.