NCT06144086已完成2 期
A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
Kiminori Kimura, MD6 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- ALBI score
研究概览
简要总结
This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.
详细描述
This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.
Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.
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 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
- •Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA < 200 copies/mL and CD4 positive T lymphocyte count >= 200 cells/µL at screening).
- •Regarding HCV, patients who had passed >= 12 months after achieving SVR at registration.
- •Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
- •Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
- •Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
- •Abdominal CT scan shows changes in liver shape and/or portal hypertension.
- •Patients with Performance Status 0-
排除标准
- •Patients with liver cirrhosis of which cause is not HCV or unknown.
- •Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
- •Patients with complication or history of malignant tumor (within 3 years before registration).
- •Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
- •Patients with active AIDS-indicator disease that require treatment.
研究组 & 干预措施
Foscenvivint
Experimental
Foscenvivint 280 mg/m2, twice a week for 24 weeks
干预措施: Foscenvivint (Drug)
结局指标
主要结局
ALBI score
时间窗: Baseline to 24 weeks after administration
Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin \[mg/dL\] x 17.1) x 0.66 + (albumin \[g/dL\] x 10 x -0.085)
次要结局
- Child-Pugh score(Baseline to 12, 24 and 28 weeks after administration)
- PT%(Baseline to 12, 24 and 28 weeks after administration)
- Liver stiffness measurement by FibroScan(Baseline to 12 and 24 weeks after administration)
- ALBI score(Baseline to 12 and 28 weeks after administration)
- Achievement in Child-Pugh classification(Baseline to 12, 24 and 28 weeks after administration)
- Achievement in Child-Pugh score(Baseline to 12, 24 and 28 weeks after administration)
- Serum fibrosis markers(Baseline to 12 and 24 weeks after administration)
- Serum albumin(Baseline to 12, 24 and 28 weeks after administration)
- FIB-4 index(Baseline to 12, 24 and 28 weeks after administration)
- Achievement in Child-Pugh classification and score(Baseline to 12, 24 and 28 weeks after administration)
- MELD score(Baseline to 12, 24 and 28 weeks after administration)
- Serum bilirubin(Baseline to 12, 24 and 28 weeks after administration)
- mALBI grade(Baseline to 12, 24 and 28 weeks after administration)
研究者
Kiminori Kimura, MD
Director, Department of Hepatology
Komagome Hospital
研究点 (6)
Loading locations...
相似试验
已完成
4 期
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis BHIV CoinfectionNCT01327547ViiV Healthcare138
已完成
4 期
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral LoadFatty Liver DiseaseHIV InfectionsNCT05898841Fundacion SEIMC-GESIDA63
招募中
2 期
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis BChronic Hep BHBVHepatitis BNCT04568265Ascentage Pharma Group Inc.122
已完成
1 期
Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia.Liver CirrhosisNCT04688034Kiminori Kimura, MD5
已完成
2 期
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With AscitesAscitesHepatic CirrhosisNCT01349335Otsuka Beijing Research Institute180