Yallaferon in Chinese Population

NCT ID: NCT02593968

Last Updated: 2015-11-02

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

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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Conditions

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HPV 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

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

Group Type EXPERIMENTAL

Recombinant Human Interferon a-2b Gel

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Recombinant Human Interferon a-2b Gel

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
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, MD

Role: CONTACT

+861066119025

Facility Contacts

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Jian Zhao, MD

Role: primary

+86-10-66119025

Other Identifiers

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Zhaoke-1504-Yallaferon

Identifier Type: -

Identifier Source: org_study_id

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