Clinical trials: Medication Administered in Error
Metachromatic Leukodystrophy (MLD)
Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD)
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
- Trial name
- IDEAMLD (NCT01510028)
- Testing
- Recombinant human arylsulfatase A
- Where
- 5 sites in Australia, Denmark and 3 more
- Volunteers
- 24 people
- Sponsor
- Shire
Child, Only, Disabilities Multiple
Pediatric Medication Therapy Management Trial
The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical…
- Conditions
- Child, Only, Disabilities Multiple, Medication Interaction, Medication Compliance
- Trial name
- pMTM (NCT05761847)
- Testing
- Pediatric Medication Therapy Management (pMTM)
- Where
- United States
- Volunteers
- 371 people
- Sponsor
- University of Colorado, Denver
Hunter Syndrome
Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment
The study is an extension of two previous studies (HGT-HIT-046 [NCT01506141] and SHP609-302 [NCT02412787]). Participants must have completed one of the previous studies.
- Trial name
- NCT06031259
- Testing
- Idursulfase-IT, Elaprase
- Where
- 4 sites in Canada, France
- Volunteers
- 6 people
- Sponsor
- Takeda
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator…
- Conditions
- Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care, Catheter-related Bloodstream Infection (CRBSI) Nos, Quality of Healthcare
- Trial name
- SEPREVEN (NCT02598609)
- Testing
- Education program for NICU caregivers
- Where
- 12 sites in France
- Volunteers
- 8,000 people
- Sponsor
- Dr Caeymaex Laurence