Phase 4
Completed N=46
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
Hereditary Angioedema Types I and II
Source: ClinicalTrials.gov NCT01467947 ↗
Enrolled (actual)
46
Serious AEs
4.4%
Results posted
Nov 2015
Primary outcomePrimary: Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies — 0 subjects
Summary
This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies |
— | — |
| SECONDARY Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies |
9; 10; 2; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require intravenous (IV) Berinert treatment during the study period.
- Male or female, ≥ 12 years of age at the time of signing informed consent.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
Exclusion Criteria
- Incurable malignancies in the last 6 months prior to study entry.
- Acquired angioedema due to C1-INH deficiency.
- All other types of angioedema not associated with C1-INH deficiency.
- Use of any C1-INH products other than Berinert within 30 days before the study, or planned use during the study.
- Immunization within 30 days prior to study entry.
- Autoimmune conditions requiring use of immunosuppressants during the study.
- Known or suspected hypersensitivity to C1-INH.
- Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration.
Data sourced from ClinicalTrials.gov (NCT01467947). 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.