NCT01541423 is a clinical trial in Hereditary Angioedema (HAE), sponsored by Shire.

Who is sponsoring NCT01541423?

NCT01541423 is sponsored by Shire.

What condition does NCT01541423 study?

NCT01541423 studies Hereditary Angioedema (HAE).

Is NCT01541423 still recruiting?

NCT01541423 is currently completed. Last updated 17 March 2021.

Last reviewed 2021-03-17 · How we verify

NCT01541423

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

Completed Last updated 17 March 2021

What this trial tests

trial in Hereditary Angioedema (HAE) in 83 participants. Completed in 25 September 2016.

Timeline

11 May 2012

Primary endpoint
25 September 2016

25 September 2016

Quick facts

Lead sponsor	Shire
Status	Completed
Study type	OBSERVATIONAL
Enrollment	83
Start date	11 May 2012
Primary completion	25 September 2016
Estimated completion	25 September 2016
Sites	20 locations across France, Italy, Belgium, United Kingdom, Germany, Spain

Conditions studied

Hereditary Angioedema (HAE) — all drugs for Hereditary Angioedema (HAE) →

Sponsor

Shire — full company profile →

Who can join

Eligibility, any sex, with Hereditary Angioedema (HAE). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hereditary Angioedema (HAE)

Currently open trials in the same condition.

NCT07251933 — A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries · recruiting
NCT07046806 — Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients · Phase 1, PHASE2 · recruiting
NCT06806618 — HAE Burden and Crisis Management · recruiting
NCT06846398 — A Phase 2 in Adult Subjects With Hereditary Angioedema · Phase 2 · active not recruiting
NCT05469789 — A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) · active not recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01541423 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 17 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01541423.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing