LONG TERM SAFETY & EFFICACY OF LANREOTIDE FOR TREATMENT OF ACROMEGALICS

长期安全

• 批准号: 6305835
• 负责人: DAVID L KLEINBERG
• 金额: $ 2.1万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6305835
• 关键词: acromegaly; clinical research; drug adverse effect; drug screening /evaluation; endocrine disorder chemotherapy; hormone therapy; human subject; human therapy evaluation; insulinlike growth factor; peptide hormone analog; somatostatin; somatotropin

The objectives of this open-label trial are to investigate the long-term safety and efficacy of lanreotide (IPSTYL) in the treatment of acromegaly by using normalization of GH and IGF-1 levels to guide dosing. Subjects must have been enrolled in a prior trial of IPSTYL. Secondary objectives are to investigate the efficacy and safety of IPSTYL in terms of tumor response, ability to control/reduce symptoms of acromegaly, adverse events and normalization of IGF-1 levels in a group of patients who have near normal levels.

这项开放标签试验的目的是通过GH和IGF-1水平的标准化来指导剂量，以研究兰瑞肽(IPSTYL)治疗肢端肥大症的长期安全性和有效性。受试者必须事先参加过IPSTYL的试验。第二个目标是研究IPSTYL在肿瘤反应、控制/减少肢端肥大症症状的能力、不良事件以及IGF-1水平正常化方面的有效性和安全性。