Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

Shire

Status and phase: Completed; Phase 2

Conditions: Hereditary Angioedema (HAE)

Treatments: Biological: CINRYZE with rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756157

2012-000083-24 (EudraCT Number)

0624-206

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups

SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2

Experimental group

Description:

SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks.

Treatment:

Biological: CINRYZE with rHuPH20

SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1

Experimental group

Description:

SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks.

Treatment:

Biological: CINRYZE with rHuPH20