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Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections

Primary Purpose

HPV Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Yallaferon®
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HPV Infection

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 30 to 65 years of age the sex life of female patients;
  2. , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;
  3. , 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 Criteria:

  • (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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Observation

    Drug

    Arm Description

    subject only got observation

    subject were treated with Yallaferon®， the recombinant human interferon α-2b gel

    Outcomes

    Primary Outcome Measures

    difference of hr-HPV DNA negative conversion rate
    Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups.

    Secondary Outcome Measures

    Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.
    Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. Evaluation criteria: Negative conversion was defined as all positive hr-HPV DNA at baseline turning negative. Non-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative.

    Full Information

    First Posted
    March 26, 2013
    Last Updated
    April 4, 2013
    Sponsor
    Lee's Pharmaceutical Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01824992
    Brief Title
    Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections
    Official Title
    a Multi-sites, Randomized, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lee's Pharmaceutical Limited

    4. Oversight

    5. Study Description

    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 clinical negative conversion. 285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HPV Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    325 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Observation
    Arm Type
    No Intervention
    Arm Description
    subject only got observation
    Arm Title
    Drug
    Arm Type
    Experimental
    Arm Description
    subject were treated with Yallaferon®， the recombinant human interferon α-2b gel
    Intervention Type
    Drug
    Intervention Name(s)
    Yallaferon®
    Other Intervention Name(s)
    Yallaferon®， the recombinant human interferon α-2b gel
    Primary Outcome Measure Information:
    Title
    difference of hr-HPV DNA negative conversion rate
    Description
    Primary efficacy endpoint was the difference of hr-HPV DNA negative conversion rate on the 6th month between the two groups.
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.
    Description
    Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups. Evaluation criteria: Negative conversion was defined as all positive hr-HPV DNA at baseline turning negative. Non-negative conversion was defined as at least one of the positive hr-HPV DNA at baseline not turning negative.
    Time Frame
    six months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: (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.

    12. IPD Sharing Statement

    Learn more about this trial

    Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections

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