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COMPLETED Phase 2

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

NCT01426763 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • BIOLOGICAL CINRYZE with rHuPH20

Study Locations (4)

Arizona

  • ViroPharma Investigational Site — Scottsdale

California

  • ViroPharma Investigational Site — Walnut Creek

Georgia

  • ViroPharma Investigational Site — Atlanta

Texas

  • ViroPharma Investigational Site — Dallas

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2011-09-12
Est. Completion 2011-11-28
Phase Phase 2

Sponsor

Shire

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01426763

The ClinicalTrials.gov registry entry for NCT01426763 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 1 intervention — of which CINRYZE with rHuPH20 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01426763 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01426763 about?

NCT01426763 is a clinical study titled "A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase". 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 phar...

What is the current status of trial NCT01426763?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-09-12. Estimated completion is 2011-11-28.

What conditions does trial NCT01426763 study?

This clinical trial studies the following conditions: Hereditary Angioedema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01426763?

The interventions under investigation include: CINRYZE with rHuPH20 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01426763?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01426763 being conducted?

This trial has 4 study locations across Arizona, California, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial