A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

June 16, 2021 updated by: Shire

An Open-label Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Hereditary Angioedema

The objectives of the study are to:

  1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497)
  2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20
  3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • ViroPharma Investigational Site
    • California
      • Walnut Creek, California, United States, 94598
        • ViroPharma Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • ViroPharma Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • ViroPharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
  4. Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.

Exclusion Criteria:

To be eligible for this protocol, a subject must not:

  1. Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
  2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
  3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
  4. 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.
  5. Have a history of abnormal blood clotting.
  6. Have a history of allergic reaction to products containing C1 INH or other blood products.
  7. Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
  8. Be pregnant or breastfeeding.
  9. Have received an investigational study drug within 30 days prior to the first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SC CINRYZE with rHuPH20 Dose Level 1
Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
Other Names:
  • C1 esterase inhibitor (human)
  • Recombinant human hyaluronidase
Experimental: SC CINRYZE with rHuPH20 Dose Level 2
Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
Other Names:
  • C1 esterase inhibitor (human)
  • Recombinant human hyaluronidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 18 days
18 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change C1 Inhibitor (C1INH)
Time Frame: 18 days
Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
18 days
Mean Change C4 Compliment
Time Frame: 18 days
Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
18 days
Number of Subjects With C1 INH Antibodies
Time Frame: Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4)
Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2011

Primary Completion (Actual)

November 28, 2011

Study Completion (Actual)

November 28, 2011

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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