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

Papillomavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00117884
• Other study ID #: 1537-851B
• Secondary ID: U1111-1127-5850
• Status: Terminated
• Phase: Phase 2
• First received: July 1, 2005
• Last updated: August 16, 2016
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clearance of high-risk human papillomavirus infection.		At each visit	No
Secondary	Proportion of subjects with evidence of regression to normal cytology.		Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).	No
Secondary	Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).		At each visit	No
Secondary	Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.		Visits 1-3 as assigned by group	No
Secondary	Time to progression of disease to precancer.		Visits 1-3 as assigned by group	No
Secondary	Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).		At each visit	No