Papillomavirus InfectionsPhase 2NCT00312286
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
A Phase 2 study testing 851B in people with Papillomavirus Infections, run by Takeda at 93 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- 851B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 538 participants
- Where
- 93 sitesin 3 countries
- Study dates
- Apr 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 36Show fewer
- 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.
Trial locations and contacts
93 sites in 3 countries.
93 sites in 3 countries
United States88 sites
Study site
Albuquerque, New Mexico
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Aventura, Florida
Study site
Birmingham, Alabama
Study site
Bismarck, North Dakota
Study site
Boise, Idaho
Study site
Boynton Beach, Florida
Study site
Bristol, Tennessee
Study site
Carmichael, California
Study site
Carrollton, Texas
Study site
Chandler, Arizona
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Chaska, Minnesota
Study site
Chattanooga, Tennessee
Study site
Clarksville, Tennessee
Study site
Clearwater, Florida
Study site
Colorado Springs, Colorado
Study site
Colton, California
Study site
Columbia, South Carolina
Study site
Dallas, Texas
Study site
Danbury, Connecticut
Study site
Decatur, Georgia
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Enterprise, Alabama
Study site
Erie, Pennsylvania
Study site
Eugene, Oregon
Study site
Evansville, Indiana
Study site
Fargo, North Dakota
Study site
Fort Myers, Florida
Study site
Gallipolis, Ohio
Study site
Greenville, South Carolina
Study site
Groton, Connecticut
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Idaho Falls, Idaho
Study site
Iowa City, Iowa
Study site
Jonesboro, Arkansas
Study site
Las Vegas, Nevada
Study site
Lebanon, New Hampshire
Study site
Leesburg, Florida
Study site
Longmont, Colorado
Study site
Louisville, Colorado
Study site
Louisville, Kentucky
Study site
Marrero, Louisiana
Study site
Medford, Oregon
Study site
Memphis, Tennessee
Study site
Metairie, Louisiana
Study site
Miami, Florida
Study site
Montgomery, Alabama
Study site
Nashville, Tennessee
Study site
New Bern, North Carolina
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Oklahoma City, Oklahoma
Study site
Paw Paw, Michigan
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Plano, Texas
Study site
Plantation, Florida
Study site
Pottstown, Pennsylvania
Study site
Reno, Nevada
Study site
Renton, Washington
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Sandy City, Utah
Study site
Santa Rosa, California
Study site
Savannah, Georgia
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
The Bronx, New York
Study site
Tucson, Arizona
Study site
Virginia Beach, Virginia
Study site
Watertown, South Dakota
Study site
West Palm Beach, Florida
Study site
West Reading, Pennsylvania
Study site
Winston-Salem, North Carolina
Study site
Woodstock, Georgia
Study site
Wynnewood, Pennsylvania
Canada4 sites
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Study site
Toronto
Study site
Winnipeg, Manitoba
About this study
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
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.
Read the 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
- Being tested
- 851B
- 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
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
851BDrug
851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 3.0% formulation, gel, topically, once a week for 1 cycle.
851BDrug
851B 3.0% formulation, gel, topically, once a week for 2 cycles.
851BDrug
851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
851BDrug
851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B placebo-matching gel, topically, once a week for 1 cycle.
851BDrug
851B placebo-matching gel, topically, twice a week for 1 cycle.
851BDrug
851B placebo-matching gel, topically, once a week for 2 cycles.
851BDrug
851B placebo-matching gel, topically, twice a week for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 851B |
| 2 | Experimental | Not described Receives: Drug: 851B |
| 3 | Experimental | Not described Receives: Drug: 851B |
| 4 | Experimental | Not described Receives: Drug: 851B |
| 5 | Experimental | Not described Receives: Drug: 851B |
| 6 | Experimental | Not described Receives: Drug: 851B |
| 7 | Experimental | Not described Receives: Drug: 851B |
| 8 | Placebo comparator | Not described Receives: Drug: 851B |
| 9 | Placebo comparator | Not described Receives: Drug: 851B |
| 10 | Placebo comparator | Not described Receives: Drug: 851B |
| 11 | Placebo comparator | Not described Receives: Drug: 851B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clearance of high-risk human papillomavirus infection.
Measured: At each visit
Secondary outcomes (5)
Proportion of subjects with evidence of regression to normal cytology.
Measured: 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).
Measured: At each visit
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.
Measured: Visits 1-3 as assigned by group
Time to progression of disease to precancer.
Measured: 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).
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312286
- Sponsor's protocol ID
- 1547-851B
- Other IDs
- U1111-1127-5771
- Status last verified
- Sep 2016
- First submitted
- 6 Apr 2006
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00312286
- Acronym / sponsor ID
- 1547-851B
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 538 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit.
Key exclusion criteria (36 listed)
- 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:
- The Subject has a history of hypersensitivity to any components of the gel formulation or to iodine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 1 |
| 851B851B 1.5% formulation, gel, topically, twice a week for 1 cycle. | Drug | 2 |
| 851B851B 1.5% formulation, gel, topically, twice a week for 2 cycles. | Drug | 3 |
| 851B851B 3.0% formulation, gel, topically, once a week for 1 cycle. | Drug | 4 |
| 851B851B 3.0% formulation, gel, topically, once a week for 2 cycles. | Drug | 5 |
| 851B851B 3.0% formulation, gel, topically, twice a week for 1 cycle. | Drug | 6 |
| 851B851B 3.0% formulation, gel, topically, twice a week for 2 cycles. | Drug | 7 |
| 851B851B placebo-matching gel, topically, once a week for 1 cycle. | Drug | 8 |
| 851B851B placebo-matching gel, topically, twice a week for 1 cycle. | Drug | 9 |
| 851B851B placebo-matching gel, topically, once a week for 2 cycles. | Drug | 10 |
| 851B851B placebo-matching gel, topically, twice a week for 2 cycles. | Drug | 11 |
Primary outcome
Time to clearance of high-risk human papillomavirus infection.
Time frame: At each visit
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
93 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 851B in people with Papillomavirus Infections, run by Takeda at 93 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clearance of high-risk human papillomavirus infection. (time frame: At each visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.