NCT00264732已完成2 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Amolimogene (ZYC101a) in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN 2/3) of the Uterine Cervix
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
- Eisai Inc.
- 入组人数
- 251
- 试验地点
- 26
- 主要终点
- Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.
详细描述
This is a double-blind study, so neither the patient not the doctor will know which treatment has been assigned.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be considered for enrollment, patients must:
- •Have an abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS], atypical squamous cells, cannot exclude high grade [ASC-H], low grade squamous intraepithelial lesion [LSIL], high grade squamous intraepithelial lesion [HSIL]) result within 6 months of screening visit.
- •Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.
- •Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.
- •Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.
- •Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.
- •Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).
- •Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.
- •Be willing to sign an Institutional Review Board (IRB) approved informed consent. Minors must have the consent of a parent or legal guardian as required by local laws and regulations.
- •Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).
- •Be capable of complying with the protocol.
- •Not have other illnesses that would put the patient at undue risk for participation in the trial or would interfere with the required clinical observations.
- •Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.
- •Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.
- •Not have an active systemic infection requiring treatment.
- •Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).
- •Not be positive for HIV antibody.
- •Not be pregnant or lactating.
- •Not plan to use a cervical cap or diaphragm during the study.
- •Not have been treated with any investigational agent within 30 days prior to randomization in this trial.
- •Not have had prior gene therapy.
- •Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.
- •Be willing to consent to an excisional procedure, such as LEEP or cold-knife cone procedure, if indicated.
- •Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Amolimogene (Drug)
2
Experimental
干预措施: Amolimogene (Drug)
3
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.
时间窗: 24 weeks after enrollment.
次要结局
- Histology based on biopsy to determine the proportion of pts. w/resolution of CIN2/3. This is the same as primary efficacy variable in determination of presence or absence of CIN2/3, but excludes pts. with excisional procedure or cytology information.(24 weeks after enrollment.)
- Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal."(24 weeks after enrollment.)
- Clearing or persistence of lesions based on colposcopic findings to examine the proportion of patients with "no lesion" versus "at least one lesion."(24 weeks after enrollment.)
- Pap smear cytology.(24 weeks after enrollment.)
- Clearing or persistence of original human papillomavirus (HPV) subtype as determined by HPV typing to present the number and percent of patients with absence of all HPV.(24 weeks after enrollment.)
研究者
研究点 (26)
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