RPCEC00000038
Completed
Phase 2
Intramuscular application of a new freeze-dried formulation of albumin-free recombinant human alpha-2b interferon in Acuminate Condyloma patients.
Center for Genetic Engineering and Biotechnology (CIGB)0 sites30 target enrollmentDecember 20, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Tumor Virus Infections
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical and histological diagnosis positive to Acuminate Condyloma by papilloma virus. Patients of both sexes with Acuminate Condyloma lesions in external genitals, perianal region, and inner thighs. Patients aged 18 to 60\. No topical or systemic treatment with IFN or any other antiviral drug one month before inclusion in the study. Reproductive\-age women using any non\-hormonal contraceptive. Patient’s consent in writing to participate in the study.
Exclusion Criteria
- •Other sexually transmitted diseases (syphilis, infectious urethritis, AIDS). Antiviral or immunosuppressor (corticosteroid, cytostatic) therapy three months before commencing INF treatment. Severe systemic and chronic diseases affecting the patient’s general condition and modifying therapeutic response, including malignant neoplasias and immunodeficiency. Lesion sepsis demanding systemic antibiotic treatment. Pregnancy or breastfeeding. Patients with history of hypersensitivity to alpha INF or any formulation component.
Outcomes
Primary Outcomes
Not specified
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