KCT0001585招募中未知
A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate the Safety of GX-188E, a DNA-base Therapeutic Vaccine, Administered Intramuscularly by Eletroporation (EP) in HPV Type 16 and /or 18 Positive Patients With Cervical Intraepithelial Neoplasia 3 (CIN3)
Gegexine0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- Female
入选标准
- •1) Voluntarily signed informed consent form after receiving education about this study and the investigational product.
- •2) Female aged between 19 and 50 years
- •3) Positive test results for HPV Type 16 and/or Type 18
- •4) Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
- •5) Entire cervical area including entire squamocolumnar junction is visualized through colposcopy
- •6) Eligible based on screening test results.
- •7) Promised not to get pregnant throughout the study
排除标准
- •1) Suspected Adenocarcinoma in situ
- •2) Malignant cancer more than Stage I
- •3) Pregnancy or breastfeeding
- •4) Participation in clinical trials within 30 days of the screening visit
- •5) Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment
- •6) Administered with systemic steroid(as a standard with Prednisolone, more than 20mg/day for every 14 days or more) within 3 months of Day 1(including ointment, eye drops, inhalated or nasal, intra-ligamental or intra-articular injection, but not applicable if injected every other day
- •7) Administered any blood products within 3 months prior to the screening visit
- •8) Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)
- •9) Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV
- •10) Severe hepatopathy which is Class C according to Child-Pough's classification
- •11) Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
- •12) CPK test results more than 2.5 times the upper limit of normal
- •13) Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
- •14) History of severe adverse drug events or severe allergic diseases
- •15) History of epilepsy or convulsion within 2 years prior to the screening visit
- •16) At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
- •17) The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm
- •18) Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
- •19) Sinus bradycardia whose resting heart rate < 50 beats/min
- •20) Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
- •21) Abnormal electrocardiography(ECG) including arrhythmia
- •22) Artificial implants or metallic implants
- •23) Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
研究者
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