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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

NCT01095497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-07-09

Study results available
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Summary

The objectives of the study are to:

1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema
2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection
3. Assess the immunogenicity of CINRYZE following subcutaneous administration

Conditions

Interventions

BIOLOGICAL

CINRYZE

C1 esterase inhibitor (human)

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-07
Primary Completion
2010-12-16
Completion
2010-12-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095497 on ClinicalTrials.gov