Yallaferon in Chinese Population

Lee's Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: HPV Infection

Treatments: Drug: Recombinant Human Interferon a-2b Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02593968

Zhaoke-1504-Yallaferon

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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

Treatment:

Drug: Recombinant Human Interferon a-2b Gel

Plcaebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo