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

NCT00117884 | Terminated Phase 2

• 2 other identifiers: 1537-851BU1111-1127-5850
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 23

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.

Conditions

Papillomavirus Infections

Keywords

Papillomavirus infections;; Cervix Dysplasia

Outcome Measures

Primary Outcomes (1)

• Time to clearance of high-risk human papillomavirus infection.

  At each visit

Secondary Outcomes (5)

• Proportion of subjects with evidence of regression to normal cytology.

  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).

  At each visit

• Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.

  Visits 1-3 as assigned by group

• Time to progression of disease to precancer.

  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

Study Arms (11)

1

EXPERIMENTAL

Drug: 851B

2

EXPERIMENTAL

Drug: 851B

3

EXPERIMENTAL

Drug: 851B

4

EXPERIMENTAL

Drug: 851B

5

EXPERIMENTAL

Drug: 851B

6

EXPERIMENTAL

Drug: 851B

7

EXPERIMENTAL

Drug: 851B

8

EXPERIMENTAL

Drug: 851B

9

EXPERIMENTAL

Drug: 851B

10

EXPERIMENTAL

Drug: 851B

11

EXPERIMENTAL

Drug: 851B

Interventions

851B DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to be on acceptable method of birth control
• Have a Pap smear result of LSIL or ASCUS
• Is high risk HPV positive

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (23)

Unknown Facility

Colton, California, 92324, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Colorado Springs, Colorado, 80910, United States

Location

Unknown Facility

Boynton Beach, Florida, 33461, United States

Location

Unknown Facility

Tampa, Florida, 33607, United States

Location

Unknown Facility

Augusta, Georgia, 30912, United States

Location

Unknown Facility

Savannah, Georgia, 31405, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Moorestown, New Jersey, 08057, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Charlotte, North Carolina, 28203, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Arlington, Texas, 76012, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Renton, Washington, 98055, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Unknown Facility

Spokane, Washington, 99207, United States

Location

Unknown Facility

Québec, Quebec, G1S 2L6, Canada

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 11, 2005
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

CA (1); US (22)