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

NCT00312286 | Terminated Phase 2

• 2 other identifiers: 1547-851BU1111-1127-5771
• Study Type: interventional
• Target: 538
• Locations: 3 countries
• Sites: 93

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

Cervical Neoplasms; Drug Therapy; Human Papillomavirus; Cervical Human Papillomavirus; Cervical Dysplasia; Chemoprevention; High Risk Cervical Human Papillomavirus; Atypical Squamous Cells of Undetermined Significance; Low Grade Intraepithelial Lesions

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

PLACEBO COMPARATOR

Drug: 851B

9

PLACEBO COMPARATOR

Drug: 851B

10

PLACEBO COMPARATOR

Drug: 851B

11

PLACEBO COMPARATOR

Drug: 851B

Interventions

851B DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• (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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (93)

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Birmingham, Alabama, United States

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Enterprise, Alabama, United States

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Huntsville, Alabama, United States

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Carmichael, California, United States

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Colton, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Colorado Springs, Colorado, United States

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Longmont, Colorado, United States

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Louisville, Colorado, United States

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Danbury, Connecticut, United States

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Groton, Connecticut, United States

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Aventura, Florida, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Woodstock, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Evansville, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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Detroit, Michigan, United States

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Paw Paw, Michigan, United States

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Chaska, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Gallipolis, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Watertown, South Dakota, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Clarksville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Sandy City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Toronto, Canada

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Rio Piedras, Puerto Rico

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MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix

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; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions; Morphological and Microscopic Findings

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: April 6, 2006
• First Posted: April 10, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

CA (4); PR (1); US (88)