NCT00737594终止2 期
A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
研究概览
简要总结
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
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
- Double (Participant, Investigator)
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
- •Patient is >= 18 years of age.
- •Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
- •Patient has clinical diagnosis of cirrhosis.
- •Patient has undergone variceal banding.
排除标准
- •Patient has a Child-Pugh score >
- •Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
- •Variceal banding procedure was performed within 1 month of the screening visit.
- •Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
- •Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
- •Patient has hepatocellular carcinoma that is being medically treated or is advanced.
- •Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
- •Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
- •Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
研究组 & 干预措施
Placebo TID
Placebo Comparator
Participants receive matching placebo capsules three times daily (TID)
干预措施: Placebo (Drug)
12 mcg TID
Experimental
Participants receive 12 mcg Cobiprostone TID
干预措施: Cobiprostone (Drug)
18 mcg TID
Experimental
Participants receive 18 mcg Cobiprostone TID
干预措施: Cobiprostone (Drug)
结局指标
主要结局
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive AdultsHIV-1 InfectionNCT00892437Gilead Sciences85
已完成
3 期
Opioid-induced Bowel Dysfunction Pivotal Assessment of LubiprostoneOpioid-Induced Bowel DysfunctionNCT00597428Sucampo Pharma Americas, LLC437
已完成
3 期
Opioid-induced Bowel Dysfunction: Pivotal Assessment of LubiprostoneOpioid-Induced Bowel DysfunctionNCT00595946Sucampo Pharma Americas, LLC439
已完成
3 期
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)Opioid-induced Bowel DysfunctionNCT01298219Sucampo Pharma Americas, LLC439
已完成
3 期
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive AdultsHIVHIV InfectionsNCT01108510Gilead Sciences698