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CINRYZE

Phase 2

Hereditary Angioedema | Monoclonal antibody | Immunology |Takeda Pharmaceutical Company Limited|Last Updated: Jul 19, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

CINRYZE · 2 trials · 1 indication

Phase 2 2
NCT01426763A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human HyaluronidaseHereditary Angioedema
COMPLETED12 Analytics
NCT01095497A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE AdministrationHereditary Angioedema
COMPLETED26 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Hereditary AngioedemaUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
Hereditary AngioedemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study
18 days
Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
18 days in each treatment period

Secondary Endpoints

Mean Change C1 Inhibitor (C1INH)
18 days
Mean Change C4 Compliment
18 days
Number of Subjects With C1 INH Antibodies
Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
SC CINRYZE with rHuPH20 Dose Level 1EXPERIMENTALSubcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
SC CINRYZE with rHuPH20 Dose Level 2EXPERIMENTALSubcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
IV CINRYZE First, Then SC CINRYZE Dose 1EXPERIMENTAL -
IV CINRYZE First, Then SC CINRYZE Dose 2EXPERIMENTAL -

Interventions

NameTypeDescription
CINRYZE with rHuPH20BIOLOGICAL -
CINRYZEBIOLOGICALC1 esterase inhibitor (human)
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: To be eligible for this protocol, a subject must: 1. Provide informed consent/assent, as appropriate. 2. Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study. 3. During the 3 consecutive months prior to screening, ha...

Countries:United States
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Frequently asked questions about CINRYZE

What is CINRYZE used for?

CINRYZE is used for the treatment and prevention of attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. It is being studied in clinical trials for patients with HAE, including children under the age of 12.

Who makes CINRYZE?

CINRYZE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is conducting clinical trials to evaluate the safety and efficacy of CINRYZE for hereditary angioedema.

What phase is CINRYZE in?

CINRYZE is in Phase 2 clinical development. It is an investigational therapy for hereditary angioedema and has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and effectiveness.

What clinical trials is CINRYZE in?

CINRYZE has been studied in several Phase 2 trials. These include NCT01095497, evaluating subcutaneous administration; NCT01095510, for children under 12; NCT01426763, testing subcutaneous delivery with recombinant human hyaluronidase; and NCT01756157, for prevention of angioedema attacks. All trials are completed.

Is CINRYZE a monoclonal antibody?

Yes, CINRYZE is a monoclonal antibody. It is being developed as a treatment for hereditary angioedema, a condition marked by recurrent swelling episodes. Clinical trials have assessed its use in both adults and children.