SSP-004184 100 mg Capsule ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
284ダイアモンド・ブラックファン貧血1

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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PhaseCountries
1EUCTR2010-019645-25-GB
(EUCTR)
19/07/201016/06/2010A 24 week trial to study the safety and tolerability of SSP-004184 in the treatment of patients with longterm iron overload who need iron chelation therapy, with the option of 72 weeks further dosing.A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy, with a 72 Week Dosing Extension. - SPD602-201 Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, ß-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure.
MedDRA version: 14.1;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: SSP-004184 50 mg Capsule
Product Code: SSP-004184 50 mg
INN or Proposed INN: Not assigned
Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide
Product Name: SSP-004184 100 mg Capsule
Product Code: SSP-004184 100 mg
INN or Proposed INN: Not assigned
Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide
Product Name: SSP-004184 250 mg Capsule
Product Code: SSP-004184 250 mg
INN or Proposed INN: Not assigned
Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide
Product Name: SSP-004184 375 mg Capsule
Product Code: SSP-004184 375 mg
INN or Proposed INN: Not assigned
Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide
Product Name: SSP-004184 500 mg Capsule
Product Code: SSP-004184 500 mg
INN or Proposed INN: Not assigned
Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazo
Shire Development LLCNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Thailand;Turkey;Italy;United Kingdom