WHO ICTRP trial
Safety and Efficacy Study of HGT-1410 Administration in Pediatric Patients with…
EUCTR2013-003450-24-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2013-003450-24-DE |
|---|---|
| Public title | Safety and Efficacy Study of HGT-1410 Administration in Pediatric Patients with Early Stage of Sanfilippo Syndrome Type A |
| Scientific title | A Randomized, Controlled, Open-label, Multicenter, Phase IIb Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in Pediatric Patients with Early Stage Mucopolysaccharidosis Type III A Disease |
| Primary sponsor | Shire Human Genetic Therapies, Inc |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;United States;Argentina;Brazil;Spain;Netherlands;Germany;Italy;United Kingdom |
| Conditions | Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA) MedDRA version: 17.1 Level: LLT Classification code 10056918 Term: Sanfilippo's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA… |
| Interventions | Product Name: Recombinant human heparan N-sulfatase (rhHNS) Product Code: HGT-1410 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available Current Sponsor code: HGT-1410 Other descriptive name: Recombinant human… |
| Registration date | Jul 11, 2013 |
| Target size | 18 |
| Secondary IDs | HGT-SAN-093;NCT02060526 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: