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NCT00894075
Single-Center, Case-Control Study of Safety, Efficacy and Pharmacokinetics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) for Treatment of Hypophosphatasia in Children
Phase 2 trial testing ENB-0040 in Hypophosphatasia. Withdrawn.
1 December 2014
Quick facts
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 July 2009 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
Drugs / interventions tested
- ENB-0040 — full drug profile →
Conditions studied
- Hypophosphatasia — all drugs for Hypophosphatasia →
Sponsor
Alexion Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 5 to 12, any sex, with Hypophosphatasia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Skeletal radiographs using a qualitative Clinical Global Impression of Change (CGI-C) scoring system
Time frame: 6 months
Sponsor's own description
This Clinical Trial is being conducted to study Hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study is to test the safety of the study drug called ENB-0040 and see what effects is has on human juveniles and HPP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00894075
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypophosphatasia
Currently open trials in the same condition.
- NCT07390240 — The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia · recruiting
- NCT06079359 — Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP · Phase 3 · active not recruiting
- NCT06079372 — Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa · Phase 3 · active not recruiting
- NCT06079281 — Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Trea · Phase 3 · active not recruiting
- NCT05234567 — A Prospective Sub-Study of the Global Hypophosphatasia Registry · recruiting
Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06015750 — Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia · Phase 4 · withdrawn
- NCT07352423 — Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants · Phase 1 · recruiting
- NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab · Phase 4 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS · Phase 4 · recruiting
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 NCT00894075 (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 Alexion Pharmaceuticals, Inc.
- Last refreshed: 3 August 2023
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/NCT00894075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing