Yallaferon in Chinese Population

October 30, 2015 updated by: Lee's Pharmaceutical Limited

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

The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Jian Zhao, MD
          • Phone Number: +86-10-66119025

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

21 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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
Experimental: Treatment
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
Drug: Recombinant Human Interferon a-2b Gel
Placebo Comparator: Plcaebo
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
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV-16 and/or HPV-18 negative conversion rate
Time Frame: 3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV-16 and/or HPV-18 negative conversion rate
Time Frame: 6 months
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
6 months
HPV-16 and/or HPV-18 negative conversion rate
Time Frame: 9 months
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
9 months
HPV-16 and/or HPV-18 negative conversion rate
Time Frame: 12 months
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
12 months
reinfection at 12 months
Time Frame: 12 months
12 months

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)

September 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhaoke-1504-Yallaferon

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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