Ovastat 5000 mg, powder for solution for infusion ( DrugBank: OVASTAT )


1 disease
IDDisease name (Link within this page)Number of trials
65Primary immunodeficiency1

65. Primary immunodeficiency


Clinical trials : 500 Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2013-005508-33-CZ
(EUCTR)
12/11/201429/07/2014Comparison of Treosulfan-based with Busulfan-based conditioning in paediatric patients with non-malignant diseasesClinical phase II trial to compare Treosulfan-based conditioning therapy with Busulfan-based conditioning prior to allogeneic haematopoietic stem cell transplantation (HSCT) in paediatric patients with non-malignant diseases - Treosulfan-based versus Busulfan-based conditioning in paediatric patients with non-malignant diseas Male and female children with non-malignant diseases requiring myeloablative conditioning treatment with following allogeneic haematopoietic stem cell transplantation (allo-HSCT) – i.e. primary immunodeficiencies, inborn errors of metabolism, haemoglobinopathies and bone marrow failure syndromes.
MedDRA version: 20.0;Level: HLT;Classification code 10021606;Term: Inborn errors of metabolism NEC;System Organ Class: 100000004850
MedDRA version: 20.0;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870
MedDRA version: 20.0;Classification code 10018903;Term: Haemoglobinopathies congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ovastat 1000 mg, powder for solution for infusion
Product Name: Ovastat 1000
INN or Proposed INN: TREOSULFAN
Trade Name: Ovastat 5000 mg, powder for solution for infusion
Product Name: Ovastat 5000
INN or Proposed INN: TREOSULFAN
Trade Name: Busilvex
INN or Proposed INN: BUSULFAN
medac Gesellschaft für klinische Spezialpräparate mbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czech Republic;Poland;Austria;Germany;Italy