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

June 14, 2016 updated by: Lee's Pharmaceutical Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Peking, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Jian Zhao, M.D.
          • Phone Number: 010-83572075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
Drug: Yallaferon®， the recombinant human interferon α-2b gel
Placebo Comparator: controlled group
received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Other: gel without active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Time Frame: three months
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.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Time Frame: six months, nine months and twelve months
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.
six months, nine months and twelve months
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

June 12, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhaoke-201509-RHI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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