Papillomavirus InfectionsPhase 2NCT00117884
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 23 sites in 2 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 40 years, women only
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- 851B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 23 sitesin 2 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing to be on acceptable method of birth control
- Have a Pap smear result of LSIL or ASCUS
- Is high risk HPV positive
Who cannot join
- No evidence of high-grade disease or glandular abnormalities,
- Complete visualization of all lesion margins and the transformation zone,
- No uncontrolled significant medical illness or sexually transmitted infections,
- Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Study site
Arlington, Texas, 76012
Study site
Augusta, Georgia, 30912
Study site
Austin, Texas, 78705
Study site
Boynton Beach, Florida, 33461
Study site
Charlotte, North Carolina, 28203
Study site
Colorado Springs, Colorado, 80910
Study site
Colton, California, 92324
Study site
Detroit, Michigan, 48201
Study site
Houston, Texas, 77004
Study site
Louisville, Kentucky, 40202
Study site
Moorestown, New Jersey, 08057
Study site
Nashville, Tennessee, 37203
Study site
New York, New York, 10032
Study site
Oklahoma City, Oklahoma, 73104
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Renton, Washington, 98055
Study site
San Diego, California, 92108
Study site
Savannah, Georgia, 31405
Study site
Seattle, Washington, 98105
Study site
Spokane, Washington, 99207
Study site
Tampa, Florida, 33607
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
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
- Papillomavirus infections;, Cervix Dysplasia
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia
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 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851BDrug
851B 0.15% formulation, 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 | Experimental | Not described Receives: Drug: 851B |
| 9 | Experimental | Not described Receives: Drug: 851B |
| 10 | Experimental | Not described Receives: Drug: 851B |
| 11 | Experimental | 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 posted11 Jul 2005 (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
- 240 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
- NCT00117884
- Sponsor's protocol ID
- 1537-851B
- Other IDs
- U1111-1127-5850
- Status last verified
- Aug 2016
- First submitted
- 1 Jul 2005
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
- ClinicalTrials.gov ID
- NCT00117884
- Acronym / sponsor ID
- 1537-851B
- Conditions
- Papillomavirus Infections
- Keywords
- Papillomavirus infections;, Cervix Dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 240 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Jul 2005 (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 | Experimental | Drug: 851B |
| 9 | Experimental | Drug: 851B |
| 10 | Experimental | Drug: 851B |
| 11 | Experimental | Drug: 851B |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to be on acceptable method of birth control
- Have a Pap smear result of LSIL or ASCUS
- Is high risk HPV positive
Key exclusion criteria (4 listed)
- No evidence of high-grade disease or glandular abnormalities,
- Complete visualization of all lesion margins and the transformation zone,
- No uncontrolled significant medical illness or sexually transmitted infections,
- Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
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 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 2 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 3 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 4 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 5 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 6 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 7 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 8 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 9 |
| 851B851B 0.15% formulation, gel, topically, twice a week for 2 cycles. | Drug | 10 |
| 851B851B 0.15% formulation, 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 19 Aug 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
23 sites in 2 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 23 sites in 2 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 3 inclusion and 4 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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. 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 19 Aug 2016.