Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections
Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
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
June 12, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJune 15, 2016
June 1, 2016
1.5 years
June 12, 2016
June 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.
three months
Secondary Outcomes (2)
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
six months, nine months and twelve months
The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups
1 year
Study Arms (2)
Treatment group
ACTIVE COMPARATORreceived 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
controlled group
PLACEBO COMPARATORreceived 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, China
MeSH Terms
Interventions
Intervention 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
June 12, 2016
First Posted
June 15, 2016
Study Start
September 1, 2015
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
June 15, 2016
Record last verified: 2016-06