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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

Tracking Information
First Submitted Date  ICMJE April 6, 2006
First Posted Date  ICMJE April 10, 2006
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
Time to clearance of high-risk human papillomavirus infection. [ Time Frame: At each visit ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
The primary objective of this study is to evaluate the efficacy of 851B gel over a range of concentrations and dosing regimens when compared to placebo based on regression of HR cervical HPV infection in women with LSIL or ASC-US.
Change History Complete list of historical versions of study NCT00312286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
  • 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). ]
  • Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy). [ Time Frame: At each visit ]
  • Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia. [ Time Frame: Visits 1-3 as assigned by group ]
  • Time to progression of disease to precancer. [ Time Frame: 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). [ Time Frame: At each visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
  • To evaluate the percentage of women who have regression to normal cytology;
  • To evaluate the effect of treatment on any cervical lesions identified at baseline colposcopy;
  • To determine the safety and tolerability of intravaginally applied 851B gel.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Papillomavirus Infections
Intervention  ICMJE
  • Drug: 851B
    851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
  • Drug: 851B
    851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
  • Drug: 851B
    851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
  • Drug: 851B
    851B 3.0% formulation, gel, topically, once a week for 1 cycle.
  • Drug: 851B
    851B 3.0% formulation, gel, topically, once a week for 2 cycles.
  • Drug: 851B
    851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
  • Drug: 851B
    851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
  • Drug: 851B
    851B placebo-matching gel, topically, once a week for 1 cycle.
  • Drug: 851B
    851B placebo-matching gel, topically, twice a week for 1 cycle.
  • Drug: 851B
    851B placebo-matching gel, topically, once a week for 2 cycles.
  • Drug: 851B
    851B placebo-matching gel, topically, twice a week for 2 cycles.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: 851B
  • Experimental: 2
    Intervention: Drug: 851B
  • Experimental: 3
    Intervention: Drug: 851B
  • Experimental: 4
    Intervention: Drug: 851B
  • Experimental: 5
    Intervention: Drug: 851B
  • Experimental: 6
    Intervention: Drug: 851B
  • Experimental: 7
    Intervention: Drug: 851B
  • Placebo Comparator: 8
    Intervention: Drug: 851B
  • Placebo Comparator: 9
    Intervention: Drug: 851B
  • Placebo Comparator: 10
    Intervention: Drug: 851B
  • Placebo Comparator: 11
    Intervention: Drug: 851B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 15, 2008)
538
Original Enrollment  ICMJE
 (submitted: April 6, 2006)
480
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312286
Other Study ID Numbers  ICMJE 1547-851B
U1111-1127-5771 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP