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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801383
Recruitment Status : Unknown
Verified June 2016 by Lee's Pharmaceutical Limited.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Cervical HPV-16 and / or HPV-18 Infection Drug: Yallaferon®, the recombinant human interferon α-2b gel Other: gel without active ingredient Phase 2 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Active Comparator: Treatment group
received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
Drug: Yallaferon®, the recombinant human interferon α-2b gel
Placebo Comparator: controlled group
received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
Other: gel without active ingredient



Primary Outcome Measures :
  1. difference of HPV-16 and/ or HPV-18 DNA negative conversion rate [ Time Frame: three months ]
    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.


Secondary Outcome Measures :
  1. difference of HPV-16 and/ or HPV-18 DNA negative conversion rate [ Time Frame: six months, nine months and twelve months ]
    Secondary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 6th, 9th and 12th month between the two groups.

  2. The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801383


Contacts
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Contact: Jian Zhao 010-83572075

Locations
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China
Peking University First Hospital Recruiting
Peking, China
Contact: Jian Zhao, M.D.    010-83572075      
Sponsors and Collaborators
Lee's Pharmaceutical Limited
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT02801383    
Other Study ID Numbers: Zhaoke-201509-RHI
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents