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Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with a history of cytological diagnosed Pap IIID, with a confirmed histological diagnosis of CIN I or II, and of confirmed HPV+ status - Interferon alpha-2b kinetics in Pap IIID women

Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with a history of cytological diagnosed Pap IIID, with a confirmed histological diagnosis of CIN I or II, and of confirmed HPV+ status - Interferon alpha-2b kinetics in Pap IIID women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006208-52-DE
Enrollment
Unknown
Registered
2009-02-09
Start date
2009-03-09
Completion date
Unknown
Last updated
2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical dysplasia (CIN I or CIN II

Interventions

Product Name: Interferon alpha-2b Cream Product Code: IFNa-2b Pharmaceutical Form: Cream INN or Proposed INN: Interferon alpha-2b CAS Number: 98530-12-2 Current Sponsor code: IFNa-2b Other descriptive

Sponsors

Helix BioPharma Cooperation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Female, pre-menopausal subjects aged 18 to 45 years inclusive - Cytological diagnosis of Pap IIID (Munich nomenclature II) not older than 12 months - Mild cervical dysplasia (CIN I) or moderate cervical dysplasia (CIN II) confirmed by histology - HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®) - Subjects must be on stable hormonal contraception, which guarantees 29 consecutive days without menstruation 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - No Ccytological diagnosis of Pap IIID within the last 12 months or at screening - Severe dysplasia (CIN III), carcinoma in situ or invasive carcinoma - History of abnormal Pap smears higher than Pap IIID - History of or current internal or external urogenital warts - History of frequently recurrent or current sexually-transmitted infection(s) or bacterial vaginosis - History or presence of other malignancies - History or presence of an immune-compromising disease, or a positive Human Immunodeficiency Virus (HIV) test result at screening - History of Hepatitis B or C, or a positive Hepatitis B or Hepatitis C test result at screening - Any other treatment of the cervical lesion during study participation (e.g. conization, laser ablation) - Contraindication for the use of hormonal contraceptives

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the pharmacokinetic (PK) profile of Interferon alpha-2b Cream in women with cytological diagnosis of Papanicolaou (Pap) IIID and confirmed Human Papillomavirus positive (HPV+) status;Secondary Objective: To investigate the efficacy and safety of Interferon alpha-2b Cream ;Primary end point(s): Assessment of systemic levels of interferon alpha-2b—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026