Phase 2
N=47
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
Hereditary Angioedema (HAE)
Bottom Line
View on ClinicalTrials.gov: NCT01756157 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Normalized Number of Angioedema Attacks During the Treatment Period — 1.58; 0.97 angioedema attacks — p=0.0523
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CINRYZE with rHuPH20 (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalized Number of Angioedema Attacks During the Treatment Period |
1.58; 0.97 | 0.0523 |
| SECONDARY Cumulative Attack-severity During the Treatment Period |
3.14; 1.81 | — |
| SECONDARY Cumulative Daily-severity During the Treatment Period |
4.63; 2.81 | — |
| SECONDARY Cumulative Symptomatic Days During the Treatment Period |
3.06; 2.14 | — |
| SECONDARY Number of Angioedema Attacks Requiring Acute Treatment During the Treatment Period |
0.99; 0.43 | — |
Summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.
Eligibility Criteria
Inclusion Criteria
- Be ≥12 years of age.
- Have a confirmed diagnosis of Hereditary Angioedema.
Exclusion Criteria
- Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug.
- Be receiving prophylactic intravenous CINRYZE that exceeds 1000 units every 3 or 4 days (maximum weekly dose 2000 units).
- Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 7 days prior to the first dose of study drug.
- If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
- History of allergic reaction to C1 INH products, including CINRYZE or other blood products.
- History of abnormal blood clotting.
- Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
Data sourced from ClinicalTrials.gov (NCT01756157). 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.