Low Dose Cyclophosphamide Treats Genital Warts
Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide
1 other identifier
interventional
104
1 country
1
Brief Summary
Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2007
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 21, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedNovember 25, 2009
November 1, 2009
2.4 years
October 21, 2009
November 24, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy
6 month
Study Arms (2)
placebo
NO INTERVENTIONcyclophosphamide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of large genital warts
You may not qualify if:
- HPV type 6 or 11 was detected negatively by PCR method.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
Related Publications (1)
Cao Y, Zhao J, Lei Z, Shen S, Liu C, Li D, Liu J, Shen GX, Zhang GM, Feng ZH, Huang B. Local accumulation of FOXP3+ regulatory T cells: evidence for an immune evasion mechanism in patients with large condylomata acuminata. J Immunol. 2008 Jun 1;180(11):7681-6. doi: 10.4049/jimmunol.180.11.7681.
PMID: 18490771BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Huang, PH.D, MD
Tongji Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2009
First Posted
October 22, 2009
Study Start
January 1, 2007
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
November 25, 2009
Record last verified: 2009-11