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NCT00432510
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Phase 1 trial testing C1 esterase inhibitor [human] (C1INH-nf) in Hereditary Angioedema in 27 participants. Completed in 28 February 2007.
28 February 2007
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 27 |
| Start date | 9 October 2006 |
| Primary completion | 28 February 2007 |
| Estimated completion | 28 February 2007 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- C1 esterase inhibitor [human] (C1INH-nf) — full drug profile →
Conditions studied
- Hereditary Angioedema — all drugs for Hereditary Angioedema →
Sponsor
Shire — full company profile →
Who can join
18 and older, any sex, with Hereditary Angioedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
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:
- PubMed search for NCT00432510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of C1 esterase inhibitor [human] (C1INH-nf)
Trials testing the same drug.
- NCT00438815 — Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks · Phase 3 · completed
- NCT00462709 — Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks · Phase 3 · completed
- NCT00289211 — C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks · Phase 3 · completed
- NCT01005888 — C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks · Phase 3 · completed
Other recruiting trials for Hereditary Angioedema
Currently open trials in the same condition.
- NCT06960213 — STOP-HAE: A Phase 3 Study of ADX-324 in HAE · Phase 3 · recruiting
- NCT06806657 — Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab · Phase 4 · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT05691361 — Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients · Phase 1, PHASE2 · active not recruiting
- NCT05505916 — An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angio · Phase 3 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT00432510 (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: 3 June 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/NCT00432510.
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