An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 88
- 主要终点
- Participants With Markedly Abnormal Change in Vital Signs and Body Weight
研究概览
简要总结
To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients
详细描述
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has completed study treatment in study FE200486 CS
- •Has completed visit 16 in study FE200486 CS
- •Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
排除标准
- 未提供
研究组 & 干预措施
Degarelix 80/80 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
干预措施: Degarelix (Drug)
Degarelix 40/40 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
干预措施: Degarelix (Drug)
Degarelix 80 + 20
In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
干预措施: Degarelix (Drug)
结局指标
主要结局
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
时间窗: 3 years
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
Liver Function Tests
时间窗: 3 years
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
次要结局
- Serum Levels of Testosterone After 1, 2, and 3 Years(3 years)