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

Phase 2

Terminated

• Conditions: Papillomavirus Infections
• Interventions: Drug: 851B

• Registration Number: NCT00117884
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-11
• Study Start: 2006-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-08
• Disposition First Submitted: 2016-08-16
• Disposition First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Disposition First Posted: 2016-08-19
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 240

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
9	851B	-
1	851B	-
2	851B	-
3	851B	-
4	851B	-
5	851B	-
6	851B	-
7	851B	-
8	851B	-
10	851B	-
11	851B	-

Primary Outcome Measures

Name	Time	Method
Time to clearance of high-risk human papillomavirus infection.	At each visit

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.	Visits 1-3 as assigned by group
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).	At each visit
Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).	At each visit
Time to progression of disease to precancer.	Visits 1-3 as assigned by group
Proportion of subjects with evidence of regression to normal cytology.	Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).