EUCTR2017-004235-36-CZ进行中（未招募）1 期
A phase 4, randomized, open label multi-centre clinical study to evaluate efficacy of Isoprinosine® in female subjects with low-grade cervical dysplasia caused by HrHPV.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ewopharma AG
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Female subjects aged between 18-47 years must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence).
- •2. Cytologically confirmed ASC-US /LSIL, or histologically confirmed CIN1, or both within the last 12 months before screening V1 visit. In case the cytological examination was not done or was negative in pre-screening period, histologically confirmed CIN 1 will prevail.
- •3. Histologically confirmed CIN I stage by central laboratory.
- •4. Positivity on HrHPV by COBAS test from cervical sample
- •5. Negative pregnancy test from urine at screening (V1) and randomization (V2) visit
- •6. Signed Informed Consent Form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 166
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with higher grade of squamous intraepithelial lesions ASC-H, HSIL (CIN II, CIN III).
- •2. Subjects using any investigational drug within 3 months before enrolment.
- •3. Subjects receiving immunosuppressive therapy (immunosuppressants, antitumor agents, etc.) at screening (V1) visit and throughout subjects’s participation in the study.
- •4. Subjects receiving treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents, or treatment with thiazide diuretics (such as hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (such as furosemide, torsemide, and ethacrynic acid) at screening (V1) visit and throughout subjects’s participation in the study.
- •5. Signs or symptoms of acute vaginal/cervical/pelvic infection at screening (V1) and randomization (V2) visit.
- •6. History of previous prophylactic HPV vaccination
- •7. Subjects with renal dysfunction (creatinine clearance <50 mL/min) in medical history, or increase of serum creatinine at screening (V1) visit assessed as clinically significant by investigator.
- •8. Subjects receiving treatment with AZT (zidovudine) at screening (V1) visit and throughout subjects’s participation in the study.
- •9. Subjects with known hypersensitivity to IAD.
- •10. Pregnant or lactating/breastfeeding female subjects.
- •11. Subjects with a history of gout, urolithiasis and clinically significant hyperuricemia assessed by investigator at the V1.
- •12. HIV positive subjects
- •13. Subjects with liver disorder (severe liver function impairment, AST and ALT value greater than 3 times the upper limit of normal
研究者
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