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Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.

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: NCT00117884
Recruitment Status : Terminated (Lack of efficacy)
First Posted : July 11, 2005
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Drug: 851B Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: 1 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 2 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 3 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 4 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 5 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 6 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 7 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 8 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 9 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 10 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 11 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.




Primary Outcome Measures :
  1. Time to clearance of high-risk human papillomavirus infection. [ Time Frame: At each visit ]

Secondary Outcome Measures :
  1. 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). ]
  2. Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy). [ Time Frame: At each visit ]
  3. Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia. [ Time Frame: Visits 1-3 as assigned by group ]
  4. Time to progression of disease to precancer. [ Time Frame: Visits 1-3 as assigned by group ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT00117884


Locations
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United States, California
Colton, California, United States, 92324
San Diego, California, United States, 92108
United States, Colorado
Colorado Springs, Colorado, United States, 80910
United States, Florida
Boynton Beach, Florida, United States, 33461
Tampa, Florida, United States, 33607
United States, Georgia
Augusta, Georgia, United States, 30912
Savannah, Georgia, United States, 31405
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Moorestown, New Jersey, United States, 08057
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Charlotte, North Carolina, United States, 28203
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Houston, Texas, United States, 77004
United States, Washington
Renton, Washington, United States, 98055
Seattle, Washington, United States, 98105
Spokane, Washington, United States, 99207
Canada
Quebec, Canada, G1S 2L6
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00117884    
Other Study ID Numbers: 1537-851B
U1111-1127-5850 ( Registry Identifier: WHO )
First Posted: July 11, 2005    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by Takeda:
Papillomavirus infections;
Cervix Dysplasia
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections