Status:
COMPLETED
Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
HPV Infection
Eligibility:
FEMALE
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and cl...
Eligibility Criteria
Inclusion
- Age 30 to 65 years of age the sex life of female patients;
- , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;
- , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive).
- 15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68
Exclusion
- (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT01824992
Start Date
March 1 2011
End Date
September 1 2012
Last Update
April 5 2013
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