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

NCT ID: NCT00312286

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-06-30

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.

Conditions

Papillomavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 1.5% formulation, gel, topically, twice a week for 1 cycle.

3

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 1.5% formulation, gel, topically, twice a week for 2 cycles.

4

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 3.0% formulation, gel, topically, once a week for 1 cycle.

5

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 3.0% formulation, gel, topically, once a week for 2 cycles.

6

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 3.0% formulation, gel, topically, twice a week for 1 cycle.

7

Group Type: EXPERIMENTAL

851B

Intervention Type: DRUG

851B 3.0% formulation, gel, topically, twice a week for 2 cycles.

8

Group Type: PLACEBO_COMPARATOR

851B

Intervention Type: DRUG

851B placebo-matching gel, topically, once a week for 1 cycle.

9

Group Type: PLACEBO_COMPARATOR

851B

Intervention Type: DRUG

851B placebo-matching gel, topically, twice a week for 1 cycle.

10

Group Type: PLACEBO_COMPARATOR

851B

Intervention Type: DRUG

851B placebo-matching gel, topically, once a week for 2 cycles.

11

Group Type: PLACEBO_COMPARATOR

851B

Intervention Type: DRUG

851B placebo-matching gel, topically, twice a week for 2 cycles.

Interventions

851B

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

Intervention Type: DRUG

851B

851B 1.5% formulation, gel, topically, twice a week for 1 cycle.

Intervention Type: DRUG

851B

851B 1.5% formulation, gel, topically, twice a week for 2 cycles.

Intervention Type: DRUG

851B

851B 3.0% formulation, gel, topically, once a week for 1 cycle.

Intervention Type: DRUG

851B

851B 3.0% formulation, gel, topically, once a week for 2 cycles.

Intervention Type: DRUG

851B

851B 3.0% formulation, gel, topically, twice a week for 1 cycle.

Intervention Type: DRUG

851B

851B 3.0% formulation, gel, topically, twice a week for 2 cycles.

Intervention Type: DRUG

851B

851B placebo-matching gel, topically, once a week for 1 cycle.

Intervention Type: DRUG

851B

851B placebo-matching gel, topically, twice a week for 1 cycle.

Intervention Type: DRUG

851B

851B placebo-matching gel, topically, once a week for 2 cycles.

Intervention Type: DRUG

851B

851B placebo-matching gel, topically, twice a week for 2 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A female subject of childbearing potential who is sexually active using contraception.
• Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration.
• Subject must be neither pregnant nor lactating from Screening throughout the duration of the study.
• Subject has 1 of the following:

• Menstruating with a stable cycle and has at least 21 non-bleeding days.
• Amenorrheic (due to injectable or extended-cycle contraceptives).
• Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit.
• Subject has a Pap test interpretation of either low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance.
• Subject has a uterine cervical sample that is high-risk human papillomavirus positive.

Exclusion Criteria

• The Subject has evidence of an uncontrolled, clinically significant medical condition as determined by the investigator.
• The Subject has a history of hemorrhagic diatheses or coagulopathy.
• The Subject has a history of toxic shock syndrome.
• The Subject has received any of the following medications in the timeframes listed below:

• 851 (in any form) or an active (non-placebo) human papillomavirus vaccine at any time prior to the screening visit.
• In the 4 weeks prior to the screening visit the subject has received:

• Interferon therapy or other therapies that promote a proinflammatory immune state, including:

• immunomodulators.
• cytotoxic drugs.
• drugs known to have major organ toxicity.
• Used a vaginal douche 72 hours prior to the screening visit.
• Received any investigational drug within 60 days of Study Day 1.
• Used in the 2 weeks prior to Study Day 1:

• oral or inhaled corticosteroids (>1000 mcg/day, fluticasone propionate >600 mg/day, or equivalent).
• systemic steroids.
• topical drugs to the anogenital area.
• NuvaRing.
• The Subject has a history of hypersensitivity to any components of the gel formulation or to iodine.
• The Subject has given birth or has had a spontaneous or induced abortion within 2 months of Study Day 1.
• The Subject uses an intrauterine device, diaphragm, NuvaRing, or additional contraceptive foam or gel for birth control.
• The Subject has:

• histology read as high-grade cervical intraepithelial neoplasia.
• cytology read as high-grade squamous intraepithelial lesion.
• cytology read as atypical glandular cytological abnormalities.
• cytology read as atypical squamous cells - cannot exclude high grade.
• cervical carcinoma of any type.
• apparent endocervical involvement.
• high-grade vulvar intraepithelial neoplasia.
• high-grade vaginal intraepithelial neoplasia.
• If the limits of a cervical lesion cannot be readily visualized.
• If the limits of the transformation zone cannot be readily visualized.
• The subject has clinical evidence of a vaginal infection or sexually transmitted infection, other than cervical human papillomavirus infection at the Study Day 1 visit.
• The Subject has had a cervical biopsy within 1 month prior to the screening visit.
• The Subject has had any previous ablative or surgical treatment of the cervix within 3 months prior to the screening visit;
• The Subject has a history of alcoholism or substance abuse within 1 year or has current alcohol or substance abuse as assessed by the investigator.
• The Subject has tested positive for human immunodeficiency virus at the screening visit or has evidence of any other immunosuppressive disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham, Alabama, United States

Enterprise, Alabama, United States

Huntsville, Alabama, United States

Montgomery, Alabama, United States

Chandler, Arizona, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Jonesboro, Arkansas, United States

Carmichael, California, United States

Colton, California, United States

San Diego, California, United States

San Francisco, California, United States

Santa Rosa, California, United States

Colorado Springs, Colorado, United States

Longmont, Colorado, United States

Louisville, Colorado, United States

Danbury, Connecticut, United States

Groton, Connecticut, United States

Aventura, Florida, United States

Boynton Beach, Florida, United States

Clearwater, Florida, United States

Fort Myers, Florida, United States

Leesburg, Florida, United States

Miami, Florida, United States

Pembroke Pines, Florida, United States

Plantation, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Decatur, Georgia, United States

Savannah, Georgia, United States

Woodstock, Georgia, United States

Boise, Idaho, United States

Idaho Falls, Idaho, United States

Evansville, Indiana, United States

Des Moines, Iowa, United States

Iowa City, Iowa, United States

Louisville, Kentucky, United States

Marrero, Louisiana, United States

Metairie, Louisiana, United States

Detroit, Michigan, United States

Paw Paw, Michigan, United States

Chaska, Minnesota, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Reno, Nevada, United States

Lebanon, New Hampshire, United States

Newark, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

The Bronx, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

New Bern, North Carolina, United States

Winston-Salem, North Carolina, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Gallipolis, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Medford, Oregon, United States

Erie, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Pottstown, Pennsylvania, United States

West Reading, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Columbia, South Carolina, United States

Greenville, South Carolina, United States

Watertown, South Dakota, United States

Bristol, Tennessee, United States

Chattanooga, Tennessee, United States

Clarksville, Tennessee, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Carrollton, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Sandy City, Utah, United States

Richmond, Virginia, United States

Virginia Beach, Virginia, United States

Renton, Washington, United States

Seattle, Washington, United States

Winnipeg, Manitoba, Canada

Ottawa, Ontario, Canada

Québec, Quebec, Canada

Toronto, , Canada

Rio Piedras, , Puerto Rico

Countries

United States; Canada; Puerto Rico

Other Identifiers

U1111-1127-5771

Identifier Type: REGISTRY

Identifier Source: secondary_id

1547-851B

Identifier Type: -

Identifier Source: org_study_id