Back to resultsEfficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Primary Purpose
Papillomavirus Infections
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
851B
851B
851B
851B
851B
851B
851B
851B
851B
851B
851B
Sponsored by
About this trial
This is an interventional treatment trial for Papillomavirus Infections focused on measuring Papillomavirus infections;, Cervix Dysplasia
Eligibility Criteria
Inclusion Criteria: Willing to be on acceptable method of birth control Have a Pap smear result of LSIL or ASCUS Is high risk HPV positive Exclusion Criteria: No evidence of high-grade disease or glandular abnormalities, Complete visualization of all lesion margins and the transformation zone, No uncontrolled significant medical illness or sexually transmitted infections, Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
7
8
9
10
11
Arm Description
Outcomes
Primary Outcome Measures
Time to clearance of high-risk human papillomavirus infection.
Secondary Outcome Measures
Proportion of subjects with evidence of regression to normal cytology.
Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.
Time to progression of disease to precancer.
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00117884
Brief Title
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Official Title
A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.
Detailed Description
Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.
Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections
Keywords
Papillomavirus infections;, Cervix Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Arm Title
8
Arm Type
Experimental
Arm Title
9
Arm Type
Experimental
Arm Title
10
Arm Type
Experimental
Arm Title
11
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
851B
Intervention Description
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Primary Outcome Measure Information:
Title
Time to clearance of high-risk human papillomavirus infection.
Time Frame
At each visit
Secondary Outcome Measure Information:
Title
Proportion of subjects with evidence of regression to normal cytology.
Time Frame
Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).
Title
Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).
Time Frame
At each visit
Title
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.
Time Frame
Visits 1-3 as assigned by group
Title
Time to progression of disease to precancer.
Time Frame
Visits 1-3 as assigned by group
Title
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).
Time Frame
At each visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing to be on acceptable method of birth control
Have a Pap smear result of LSIL or ASCUS
Is high risk HPV positive
Exclusion Criteria:
No evidence of high-grade disease or glandular abnormalities,
Complete visualization of all lesion margins and the transformation zone,
No uncontrolled significant medical illness or sexually transmitted infections,
Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
12. IPD Sharing Statement
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Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
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