NCT01157143已完成1 期
Phase I, Double Blind, Parallel-Group, Multi-center, Gene Expression (Synthesis of FGF-1 mRNA) and Tolerability Study of Increasing Single Dose of NV1FGF Administered by Intra-Muscular Injection in Subjects With Severe Peripheral Artery Occlusive Disease (PAOD) Planned to Undergo Amputation Above the Ankle
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
- Sanofi
- 入组人数
- 6
- 主要终点
- Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site
研究概览
简要总结
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.
Secondary objectives :
- To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF
- To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)
- To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)
- To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma
- To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site
- To collect data from plasma NV1FGF pharmacokinetics
- To evaluate healing of the amputation site
详细描述
Screening of 1 to 4 weeks before study drug administration; Single study drug administration 3 to 8 days before planned amputation; 6 months of follow up
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
- •Subjects with prior decision for amputation above the ankle because of severe PAOD
- •Males or females above 18 years
- •Females must be either:
- •Non pregnant, non lactating , having practicing a medically accepted method of birth control for more than 2 months prior screening visit;
- •or surgically sterilized (tubal ligation or hysterectomy)
- •or post menopausal for at least one year
排除标准
- •Subjects with urgent need for amputation that cannot await until completion of the screening period (up to 4 weeks), added to the minimum required 48 hours between study test medication administration and tissue sample collection
- •Previous or current history of malignant disease (subjects with successful tumor resection more than 5 years -without any recurrence- prior to study start could be enrolled)
- •Abnormal Chest X-ray or mammography with suspicion of malignant disease
- •Positive stool hemoccult (except in case of hemorrhoids or any other identified cause with no malignancy origin)
- •Men with positive Prostate Specific Antigen (PSA) (above 2.5 ng/ml in subjects < 50 years and above 5 ng/ml in subjects above 50 years)
- •Females with Papanicolaou smear of Class IV or Class V characterization
- •Serious concomitant medical conditions not adequately controlled
- •Alcohol or drug abuse
- •Active proliferate retinopathy defined by the presence of new vessel formation and scarring
- •Participation in clinical trials of non-approved experimental agents within four weeks before study entry;
- •Positive serology for HIV1 or 2
- •Creatinine above 2.0 mg/dl (176 µmol/l), unless the subject is on hemodialysis / peritoneal dialysis and diagnosed with complete and irreversible renal failure or end-stage renal disease (ESRD)
- •Subjects who had a stroke or a neurological deficit presumably due to a stroke, within 3 months prior to study treatment (Amendment #1)
- •Alpha-fetoprotein (AFP) in serum > 15 µg/l, unless liver ultrasound ruled out any malignant disease
- •Positive serology for hepatitis B or C, unless liver ultrasound ruled out any malignant disease.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
NV1FGF 500 μg
Experimental
8 intramuscular injections for a total of 500 μg administered in one single administration 3 to 8 days before major amputation
干预措施: XRP0038 (NV1FGF) (Drug)
NV1FGF 2000 μg
Experimental
8 intramuscular injections for a total of 2000 μg administered in one single administration 3 to 8 days before major amputation
干预措施: XRP0038 (NV1FGF) (Drug)
NV1FGF 4000 μg
Experimental
8 intramuscular injections for a total of 4000 μg administered in one single administration 3 to 8 days before major amputation
干预措施: XRP0038 (NV1FGF) (Drug)
结局指标
主要结局
Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site
时间窗: 3 to 8 days after amputation
次要结局
- Detection of FGF-1 protein (by immunohistochemistry) in injected tissues (injection and remote site)(3 to 8 days after amputation)
- Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at remote site(3 to 8 days after amputation)
- Detection of FGF-1 receptor (by immunohistochemistry) in injected tissues (injection and remote site)(3 to 8 days after amputation)
- Detection of NV1FGF (by real-time PCR) in injected tissues (injection and remote site), in multiple organs/tissues when appropriate, and in plasma(2 months)
- Evaluation of healing of the amputation site(6 months)
研究者
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