NCT00503347已完成1 期
A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
Peregrine Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- • Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis
研究概览
简要总结
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
详细描述
OBJECTIVES:
- To determine the safety and tolerability of bavituximab administered as multiple intravenous (IV) infusions to patients co-infected with HCV and HIV
- To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
- To define the maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Written informed consent has been obtained
- •Adults 18 years of age or older
- •HIV infection documented by detectable HIV RNA PCR
- •Absolute CD4+ > 300 cells/mm3
- •Chronic hepatitis C infection based on history and detectable serum HCV RNA
- •Serum alanine aminotransferase (ALT) above normal limits and/or historical biopsy consistent with hepatitis C
- •Complete blood counts within normal limits
- •Normal renal function (serum creatinine within normal limits)
- •PT/INR and aPTT within normal limits
- •All patients of reproductive potential must agree to use an approved form of barrier contraception or agree not to become pregnant while taking study medications and for 30 days after study completion. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
排除标准
- •HCV or HIV antiviral therapy within 4 weeks of Day 0
- •Prior exposure to any chimeric antibody
- •Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease.
- •Decompensated clinical liver disease, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
- •Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
- •Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- •Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)]. A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.
- •Concurrent therapy with oral or parenteral anticoagulants
- •Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
- •Investigational therapy within 4 weeks of Day 0
- •Major surgery within 4 weeks of Day 0
- •Pregnant or nursing women
- •Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- •Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- •A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
- •A history of any condition requiring treatment (past or current) with coumarin-type agents
- •Cardiac arrhythmia requiring medical therapy
- •Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
- •Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
- •Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function. Corticosteroids administered as pre-treatment, or to treat an adverse event, are allowed.
研究组 & 干预措施
1
Experimental
0.3 mg/kg
干预措施: bavituximab (Drug)
2
Experimental
1 mg/kg
干预措施: bavituximab (Drug)
3
Experimental
3 mg/kg
干预措施: bavituximab (Drug)
4
Experimental
6 mg/kg
干预措施: bavituximab (Drug)
结局指标
主要结局
• Adverse events • Laboratory evaluations • Human anti-chimeric antibody • Pharmacokinetic analysis
次要结局
- Blood levels of HCV RNA and HIV RNA (PCR)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected SubjectsChronic Hepatitis C InfectionNCT01563536AbbVie (prior sponsor, Abbott)12
已完成
1 期
A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid TumorsNeoplasmsNCT02410512Genentech, Inc.610
已完成
2 期
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis CHepatitis C, ChronicNCT01528735Boehringer Ingelheim25
招募中
1 期
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid TumorsSolid TumorNCT05907980Chugai Pharmaceutical209
Unknown
1 期
A Phase 1 Study of ZSP1602 in Participants With Advanced Solid TumorsMedulloblastomaAdenocarcinoma of Esophagogastric JunctionSmall Cell Lung CancerNeuroendocrine NeoplasmBasal Cell CarcinomaGlioblastomaNCT03734913Guangdong Zhongsheng Pharmaceutical Co., Ltd.65