Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01059526 · ClinicalTrials.gov registry record
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
A clinical trial, sponsored by Shire.
- Completed
- Registry status
- 81
- Enrollment target
NCT01059526: Completed study, sponsored by Shire.
NCT01059526 is a clinical trial that has completed, run by Shire. The registered enrollment target is 81 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01059526 has completed, sponsored by Shire.
- COMPLETED
- Registry status
- 81 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).
Primary Outcome
Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients
Interventions
- DRUG ecallantide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2010-02-01 |
| Est. Completion | 2014-06-01 |
What the finished NCT01059526 record still lists
NCT01059526 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 81 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ecallantide is the first listed.
NCT01059526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01059526 about?
NCT01059526 is a clinical study titled "Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema". The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).
What is the current status of trial NCT01059526?
This trial is currently completed. The enrollment target is 81 participants. The study started on 2010-02-01. Estimated completion is 2014-06-01.
What interventions are being tested in trial NCT01059526?
The interventions under investigation include: ecallantide (DRUG).
Who is sponsoring clinical trial NCT01059526?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04966481 · 81 participants · Phase 3
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
- NCT05109429 · 81 participants · NA
Developing a Clinical Outcome Assessment for Opioid Craving
- NCT05112601 · 81 participants · Phase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
- NCT05305911 · 81 participants · Phase 2
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI