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

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ClinicalTrials.gov Identifier: NCT00312286
Recruitment Status : Terminated (Lack of efficacy)
First Posted : April 10, 2006
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Drug: 851B Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Phase II Study of Multiple Dosing Regimens of Intravaginally Administered 851B Gel for the Treatment of Cervical High Risk HPV Infection
Study Start Date : April 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 2 Drug: 851B
851B 1.5% formulation, gel, topically, twice a week for 1 cycle.

Experimental: 3 Drug: 851B
851B 1.5% formulation, gel, topically, twice a week for 2 cycles.

Experimental: 4 Drug: 851B
851B 3.0% formulation, gel, topically, once a week for 1 cycle.

Experimental: 5 Drug: 851B
851B 3.0% formulation, gel, topically, once a week for 2 cycles.

Experimental: 6 Drug: 851B
851B 3.0% formulation, gel, topically, twice a week for 1 cycle.

Experimental: 7 Drug: 851B
851B 3.0% formulation, gel, topically, twice a week for 2 cycles.

Placebo Comparator: 8 Drug: 851B
851B placebo-matching gel, topically, once a week for 1 cycle.

Placebo Comparator: 9 Drug: 851B
851B placebo-matching gel, topically, twice a week for 1 cycle.

Placebo Comparator: 10 Drug: 851B
851B placebo-matching gel, topically, once a week for 2 cycles.

Placebo Comparator: 11 Drug: 851B
851B placebo-matching gel, topically, twice a week for 2 cycles.




Primary Outcome Measures :
  1. Time to clearance of high-risk human papillomavirus infection. [ Time Frame: At each visit ]

Secondary Outcome Measures :
  1. 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). ]
  2. Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy). [ Time Frame: At each visit ]
  3. Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia. [ Time Frame: Visits 1-3 as assigned by group ]
  4. Time to progression of disease to precancer. [ Time Frame: Visits 1-3 as assigned by group ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312286


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Locations
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United States, Alabama
Birmingham, Alabama, United States
Enterprise, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Jonesboro, Arkansas, United States
United States, California
Carmichael, California, United States
Colton, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Longmont, Colorado, United States
Louisville, Colorado, United States
United States, Connecticut
Danbury, Connecticut, United States
Groton, Connecticut, United States
United States, Florida
Aventura, Florida, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Ft. 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
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Woodstock, Georgia, United States
United States, Idaho
Boise, Idaho, United States
Idaho Falls, Idaho, United States
United States, Indiana
Evansville, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
Iowa City, Iowa, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Marrero, Louisiana, United States
Metairie, Louisiana, United States
United States, Michigan
Detroit, Michigan, United States
Paw Paw, Michigan, United States
United States, Minnesota
Chaska, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
Reno, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
United States, North Carolina
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
United States, North Dakota
Bismark, North Dakota, United States
Fargo, North Dakota, United States
United States, Ohio
Gallipolis, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
Medford, Oregon, United States
United States, Pennsylvania
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
Pottstown, Pennsylvania, United States
West Reading, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
Greenville, South Carolina, United States
United States, South Dakota
Watertown, South Dakota, United States
United States, Tennessee
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Clarksville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
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
United States, Utah
Sandy, Utah, United States
United States, Virginia
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
United States, Washington
Renton, Washington, United States
Seattle, Washington, United States
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Canada
Quebec, Canada
Toronto, Canada
Puerto Rico
Rio Piedras, Puerto Rico
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00312286     History of Changes
Other Study ID Numbers: 1547-851B
U1111-1127-5771 ( Registry Identifier: WHO )
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Keywords provided by Takeda:
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
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections