CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
C1 inhibitor (human) [C1 INH]biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00914966
NCT00914966Phase 4Completed
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A Phase 4 Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE® (C1 Inhibitor [Human]) as Prophylactic Therapy in Subjects With Inadequately Controlled Hereditary Angioedema Attacks

Shire·interventional·Posted Jun 5, 2009·Updated Jun 23, 2021

In Brief

A Phase 4 clinical trial evaluating C1 inhibitor (human) [C1 INH] for Hereditary Angioedema. Completed, enrolled 20 participants across 11 sites.

Detailed Summary

The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3. To assess the immunogenicity of CINRYZE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2009
Enrollment StartAug 31, 2009
Primary CompletionMay 24, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.1 years ago

Interventions

C1 inhibitor (human) [C1 INH]biological