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NCT01756157 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01756157: Completed Phase 2 study, sponsored by Shire.
NCT01756157 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756157, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the perio
Interventions
- BIOLOGICAL CINRYZE with rHuPH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-02-04 |
| Est. Completion | 2013-09-13 |
| Phase | Phase 2 |
What the finished NCT01756157 record still lists
NCT01756157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which CINRYZE with rHuPH20 is the first listed.
NCT01756157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01756157 about?
NCT01756157 is a clinical study titled "Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks". 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.
What is the current status of trial NCT01756157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2013-02-04. Estimated completion is 2013-09-13.
What interventions are being tested in trial NCT01756157?
The interventions under investigation include: CINRYZE with rHuPH20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01756157?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01756157's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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