SK-5307 Phase II/III study (double-blind, parallel-group comparative study and open-label, uncontrolled extension study in subjects with acromegaly and pituitary gigantism)

Kenji Asano0 个研究点目标入组 33 人开始时间: 2023年12月21日最近更新: 2024年4月23日

适应症

试验速览

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•Subjects who were diagnosed with acromegaly or pituitary gigantism and have undergone pituitary surgery at least once, refused to undergo pituitary surgery or with contraindications to pituitary surgery.
•Subjects whose serum IGF-1 concentration is 1.3 times higher than the upper limit of normal (ULN) for age and gender at the screening test.
•Subjects who have never used existing medications to treat acromegaly or pituitary gigantism.
•Subjects on existing monotherapy to treat acromegaly or pituitary gigantism without any changes in the dosage and administration for 12 weeks prior to providing written informed consent.
•Subjects who have participated in any previous clinical study of SK-5307 and received SK-5307 (excluding placebo of SK-5307).
•Subjects deemed inappropriate by the investigator or subinvestigator.

•Subjects with a history of ineffectiveness of or significant intolerance for existing medications.
•Subjects deemed unsuitable for existing monotherapy.
•Subjects who are receiving two or more medications to treat acromegaly or pituitary gigantism at the time of the informed consent.
•Subjects who underwent pituitary radiation therapy within 3 years prior to the screening test.
•Subjects who underwent pituitary surgery within 12 weeks prior to the screening test.
•Subjects with a high risk of pituitary tumor.
•Subjects with hypersensitivity or a history of hypersensitivity to somatostatin analogue.
•Subjects with symptomatic cholelithiasis.

发起方

Kenji Asano