Skip to main content
Clinical Trials/RPCEC00000038
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.

Registry
who.int
Start Date
December 20, 2010
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Center for Genetic Engineering and Biotechnology (CIGB)

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

Similar Trials