5/25/2017
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`NCT01756157 on 2012_12_24: ClinicalTrials.gov Archive
`
`ClinicalTrials.gov archive
`
`A sen-ice oi Ihe LLS. Nalional Inslilules of Health
`
`<— History of this study
`
`1 Current version of this study
`
`View of NCT01756157 on 2012_12_24
`
`ClinicalTrials Identifier:
`
`NCT01756157
`
`Updated:
`
`2012_12_24
`
`DEMOE I1: lhe National Library of Medicine
`
`CSL EXHIBIT 1022
`
`Descriptive Information
`Brief title
`
`Official title
`
`Subcutaneous CINRYZE With Recombinant Human Hyaluronidase
`for Prevention of Angioedema Attacks
`
`A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging,
`Crossover Study to Evaluate the Safety and Efficacy of
`Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor
`[Human]) With Recombinant Human Hyaluronidase (rHuPH20) for
`the Prevention of Angioedema Attacks in Adolescents and Adults
`With Hereditary Angioedema
`
`Brief 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.
`
`Detailed description
`
`Phase
`
`Study type
`
`Study design
`
`Study design
`
`Study design
`
`Study design
`
`Study design
`
`Primary outcome
`
`Phase 2
`
`Interventional
`
`Prevention
`
`Randomized
`
`Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
`
`Crossover Assignment
`
`Safety/Efficacy Study
`
`Measure: Number of angioedema attacks during each randomized
`therapy period
`Time Frame: 8 weeks
`
`Safety Issue? No
`
`Secondary outcome
`
`Measure: Cumulative Attack-Severity during each randomized
`therapy period
`Time Frame: 8 weeks
`
`Safety Issue? No
`Description:
`
`Enrollment
`
`Condition
`
`Arm/Group
`
`This score is the sum of the maximum symptom severity recorded
`for each angioedema attack in a treatment period.
`
`40 (Anticipated)
`
`Hereditary Angioedema
`
`Arm Label: SC CINRYZE with rHuPH20 Dose Level 1 followed by
`Dose Level 2
`Experimental
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`CSL EXHIBIT 1022
`CSL v. Shire
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`

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`NCT01756157 on 2012_12_24: ClinicalTrials.gov Archive
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`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.
`
`Arm/G roup
`
`Arm Label: SC CINRYZE with rHuPH20 Dose Level 2 followed by
`Dose Level 1
`Experimental
`
`Intervention
`
`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.
`
`Arm Label: SC
`BiologicalNaccine: CINRYZE with rHuPH20
`CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2
`
`Recruitment Information
`
`Status
`
`Start date
`
`Recruiting
`2012-12
`
`Last follow-up date
`
`2013-12 (Anticipated)
`
`Primary completion
`date
`
`Criteria
`
`Inclusion Criteria:
`
`2013-11 (Anticipated)
`
`- Be 212 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.
`
`https://c|i nicaltrials.gov/archive/N CT01756157/2012_12_24
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`Gender
`
`Minimum age
`
`Healthy volunteers
`
`Both
`
`12 Years
`
`No
`
`Administrative Data
`
`Organization name
`
`Organization study ID
`
`ViroPharma
`
`0624-206
`
`Secondary ID
`
`Sponsor
`
`2012-000083—24 (EudraCT Number)
`ViroPharma
`
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`NCT01756157 on 2012_12_24: ClinicalTrials.gov Archive
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`Collaborator
`
`Halozyme Therapeutics
`
`Health Authority
`
`United States: Food and Drug Administration
`
`Health Authority
`
`Germany: Paul-Ehrlich-lnstitut
`
`Health Authority
`
`Hungary: National Institute of Pharmacy
`
`Health Authority
`
`Spain: Agencia Espafiola de Medicamentos y Productos Sanitarios
`
`Health Authority
`
`France: Afssaps - Agence francaise de sécurité sanitaire des
`produits de santé (Saint-Denis)
`
`Health Authority
`
`Romania: National Agency for Medicines and Medical Devices
`
`Health Authority
`
`Sweden: Medical Products Agency
`
`https://c|i nicalirials.gov/archive/N CT01756157/2012_12_24
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