A Phase 2 interventional study of 851B and 851B in Papillomavirus Infections, sponsored by Takeda. Terminated at 23 sites in 2 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-08-19.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 240 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Time to clearance of high-risk human papillomavirus infection.
Time frame: At each visit
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
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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