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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Genoty

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 Summary:

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.


Sponsor: Takeda

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

Original Primary Outcome: To evaluate the efficacy of multiple vaginal applications of 851B vs. placebo by assessing regression (clearance) of HR HPV as measured by Hybrid Capture 2 (according to its approved labeling).

Current Secondary Outcome:

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


Original Secondary Outcome:

  • 1) to evaluate the percentage of women who have regression to normal cytology
  • 2) to evaluate the effect of treatment on any cervical lesions identified at baseline colposcopy
  • 3) to determine safety and tolerability of intravaginally applied 851B gel


Information By: Takeda

Dates:
Date Received: July 1, 2005
Date Started: April 2006
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016