An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
研究概览
简要总结
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver volume ≥ 4 liter
- •≥ 20 liver cysts
- •Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
- •Abdominal distention perceived as uncomfortable
- •Frequent abdominal pain
- •Early satiety
- •Nausea (with the inclusion of dyspeptic complaints)
- •Diagnosed with ADPKD or ADPLD
- •Male and female patients of 18 years and older
- •Written informed consent
排除标准
- •Creatinine clearance < 20 ml/min
- •Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
- •Hormonal replacement therapy
- •Hormonal contraception
- •Pregnant or lactating
- •Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
- •Planned to undergo any surgery of the liver during study participation
- •Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
- •Patients with known allergies to somatostatin or its analogues or any of its components
- •Patients who received somatostatin analogues in the 6 months preceding study inclusion
研究组 & 干预措施
Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
干预措施: Lanreotide Autogel 90 mg and 120 mg (Drug)
结局指标
主要结局
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
时间窗: 6 months
Reduction of total liver volume after 6 months measured by means of CT-scan.
Reduction of total liver volume after 12 months of treatment by means of CT-scan
时间窗: 12 months
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan
时间窗: 18 months
Reduction of total liver volume after 18 months of treatment by means of CT-scan
次要结局
- Assessment of quality of life at baseline(baseline)
- Assessment of quality of life after 12 months of treatment(12 months)
- Assessment of quality of life after 18 months of treatment(18 months)
- Measurement of total liver and kidney volumes and cyst volumes at baseline.(Baseline)
- Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.(12 months)
- Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan(18 months)
- Assessment of quality of life after 6 months of treatment(6 months)
- Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan(6 months)
研究者
Dr Frederik Temmerman
Professor Dr Frederik Nevens
Universitaire Ziekenhuizen KU Leuven