Low-grade cervical dysplasia caused by HrHPV
Conditions
Interventions
Trade Name: Isoprinosine®
Pharmaceutical Form: Tablet
INN or Proposed INN: inosinum pranobexum
CAS Number: 36703-88-5
Other descriptive
Sponsors
Ewopharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the treatment with IAD contributes to the regression of low grade lesions ASC-US or LSIL (CIN I) cervical lesions associated with HrHPV infection.; Secondary Objective: Overall safety and tolerability of IAD. To evaluate whether the treatment with IAD eliminates HrHPV (confirmed by negativity of COBAS test). ;Primary end point(s): Proportion of subjects without LSIL (CIN I) lesion in 6 months after randomization.;Timepoint(s) of evaluation of this end point: 6 months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The overall safety and tolerability of IAD as assessed by evaluating of adverse events and serious adverse events (SAE) reported during the course of the study. 2. Proportion of subjects with HrHPV negative cervical samples assessed by COBAS test between IAD treatment group and control group. ;Timepoint(s) of evaluation of this end point: End of study visit | — |
Countries
Czech Republic
Contacts
Public ContactGlobal medical affairs department
Ewopharma International s.r.o.
Outcome results
None listed