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Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

Primary Purpose

Cervical HPV-16 and / or HPV-18 Infection

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yallaferon®， the recombinant human interferon α-2b gel
gel without active ingredient
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical HPV-16 and / or HPV-18 Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Age 25 to 65 years of age with the sex life of female patients;
  • HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.

Exclusion Criteria:

  • Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
  • Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
  • Associated with acute, severe bacterial or viral infection;
  • Autoimmune diseases;
  • Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
  • Allergies or allergy to the drug known ingredients;
  • History of suffering CNS diseases, epilepsy and/or psychological disorder;
  • Pregnant and lactating 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

Active Comparator

Placebo Comparator

Arm Label

Treatment group

controlled group

Arm Description

received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment

received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment

Outcomes

Primary Outcome Measures

difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.

Secondary Outcome Measures

difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Secondary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 6th, 9th and 12th month between the two groups.
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups

Full Information

First Posted
June 12, 2016
Last Updated
June 14, 2016
Sponsor
Lee's Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02801383
Brief Title
Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections
Official Title
Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

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 HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.
Detailed Description
100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 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
Cervical HPV-16 and / or HPV-18 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
Arm Title
controlled group
Arm Type
Placebo Comparator
Arm Description
received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Intervention Type
Drug
Intervention Name(s)
Yallaferon®， the recombinant human interferon α-2b gel
Intervention Type
Other
Intervention Name(s)
gel without active ingredient
Primary Outcome Measure Information:
Title
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Description
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.
Time Frame
three months
Secondary Outcome Measure Information:
Title
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Description
Secondary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 6th, 9th and 12th month between the two groups.
Time Frame
six months, nine months and twelve months
Title
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups
Time Frame
1 year

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 with the sex life of female patients; HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month. Exclusion Criteria: Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer; Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients; Associated with acute, severe bacterial or viral infection; Autoimmune diseases; Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs; Allergies or allergy to the drug known ingredients; History of suffering CNS diseases, epilepsy and/or psychological disorder; Pregnant and lactating 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
Phone
010-83572075
Facility Information:
Facility Name
Peking University First Hospital
City
Peking
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhao, M.D.
Phone
010-83572075

12. IPD Sharing Statement

Learn more about this trial

Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

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