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

NCT ID: NCT02801383

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Cervical HPV-16 and / or HPV-18 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment group

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

Group Type ACTIVE_COMPARATOR

Yallaferon®, the recombinant human interferon α-2b gel

Intervention Type DRUG

controlled group

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

Group Type PLACEBO_COMPARATOR

gel without active ingredient

Intervention Type OTHER

Interventions

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Yallaferon®, the recombinant human interferon α-2b gel

Intervention Type DRUG

gel without active ingredient

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Zhao

Role: CONTACT

010-83572075

Facility Contacts

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Jian Zhao, M.D.

Role: primary

010-83572075

Other Identifiers

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Zhaoke-201509-RHI

Identifier Type: -

Identifier Source: org_study_id

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