NCT00829192Unknown2 期
A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands
研究概览
简要总结
The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.
The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry
- •Organ transplant patients who have had at least one biopsy-positive SCC
- •Aged 18 - 75 years
- •Written informed consent to the performance of all study-specific procedures
排除标准
- •Allergy to afamelanotide (CUV1647) or the polymer contained in the implant
- •History of melanoma
- •Current pigmentary disorders such as melasma
- •Diagnosed with HIV/AIDS, or hepatitis B or C
- •Current history of drug or alcohol abuse (in the last 12 months)
- •Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures
- •Major medical or psychiatric illness
- •Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers
- •Females of child bearing potential not using adequate contraceptive measures
- •Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
- •Use of regular medications or any other factors that may affect skin pigmentation
- •Discontinuation Criteria:
- •Initiation of treatment with systemic retinoids
- •Change of class of systemic immunosuppressant treatment
研究组 & 干预措施
1
Experimental
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
干预措施: Afamelanotide (CUV1647) (Drug)
2
Placebo Comparator
Placebo implant administered subcutaneously every 60 days for 24 months
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands
时间窗: 24 months
次要结局
- To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)(24 months)
- To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group(24 months)
- To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)(24 months)
研究者
研究点 (12)
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