Yallaferon in Chinese Population
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
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 30, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 2, 2015
October 1, 2015
1 year
October 30, 2015
October 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
HPV-16 and/or HPV-18 negative conversion rate
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 Outcomes (4)
HPV-16 and/or HPV-18 negative conversion rate
6 months
HPV-16 and/or HPV-18 negative conversion rate
9 months
HPV-16 and/or HPV-18 negative conversion rate
12 months
reinfection at 12 months
12 months
Study Arms (2)
Treatment
EXPERIMENTALsubject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times
Plcaebo
PLACEBO COMPARATORsubject 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2015
First Posted
November 2, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
November 2, 2015
Record last verified: 2015-10