Back to resultsYallaferon in Chinese Population
Primary Purpose
HPV Infection
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Interferon a-2b Gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HPV Infection
Eligibility Criteria
Inclusion Criteria:
- Age 25 to 65 years of age the sex life of female patients;
- High-risk HPV 16 and/or 18 positive
- Agree to sign ICF
Exclusion Criteria:
- Cervical intraepithelial neoplasia (CIN);
- Combined with a severe fungal, trichomonas vaginitis;
- Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
- Allergies or allergy to the drug known ingredients.
- Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
- Pregnant and lactating women and to be pregnant women;
- The researchers do not consider it appropriate clinical trials.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Plcaebo
Arm Description
subject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times
subject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times
Outcomes
Primary Outcome Measures
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Secondary Outcome Measures
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 6 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 9 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
HPV-16 and/or HPV-18 negative conversion rate
hr-HPV DNA negative conversion rate will be evaluated at 12 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
reinfection at 12 months
Full Information
NCT ID
NCT02593968
First Posted
October 30, 2015
Last Updated
October 30, 2015
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT02593968
Brief Title
Yallaferon in Chinese Population
Official Title
a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot 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
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
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
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
subject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times
Arm Title
Plcaebo
Arm Type
Placebo Comparator
Arm Description
subject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interferon a-2b Gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
HPV-16 and/or HPV-18 negative conversion rate
Description
hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HPV-16 and/or HPV-18 negative conversion rate
Description
hr-HPV DNA negative conversion rate will be evaluated at 6 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Time Frame
6 months
Title
HPV-16 and/or HPV-18 negative conversion rate
Description
hr-HPV DNA negative conversion rate will be evaluated at 9 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Time Frame
9 months
Title
HPV-16 and/or HPV-18 negative conversion rate
Description
hr-HPV DNA negative conversion rate will be evaluated at 12 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
Time Frame
12 months
Title
reinfection at 12 months
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 25 to 65 years of age the sex life of female patients;
High-risk HPV 16 and/or 18 positive
Agree to sign ICF
Exclusion Criteria:
Cervical intraepithelial neoplasia (CIN);
Combined with a severe fungal, trichomonas vaginitis;
Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
Allergies or allergy to the drug known ingredients.
Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
Pregnant and lactating women and to be pregnant women;
The researchers do not consider it appropriate clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhao, MD
Phone
+861066119025
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhao, MD
Phone
+86-10-66119025
12. IPD Sharing Statement
Learn more about this trial
Yallaferon in Chinese Population
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