Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04232917
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-01-14
Brief Title:
Study of 2LPAPI on the Clearance of Genital HR-HPV Infections
Sponsor:
LaboLife
Organization:
LaboLife
Study Overview
Official Title:
Randomized Placebo-controlled Double-blind Study to Evaluate 2LPAPI Efficacy on the Clearance of Genital HR-HPV Infections
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPION
Brief Summary:
Human papillomavirus HPV is a prevalent pathogen the epidemiology of which has mostly been studied in the uterine cervix and the vagina
The KCE Report 238Cs 2015 recommends HR-HPV-positive women should not be offered colposcopy immediately Triage should be done using cytology for this purpose If cytological abnormalities ASCUS are found immediate referral should follow for diagnosis and where appropriate treatment If no abnormalities are observed in triage the subject should be offered follow-up testing cytology at six months
There is no treatment that is recommended during this lap time The 2LPAPI has been available for more than 20 years and has received a marketing authorization in Belgium by the FAMHP It is used as an immune regulator in the treatment of HR-HPV infections Since 2LPAPI has been made available clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV
The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI on the clearance of genital HR-HPV infections
The KCE Report 238Cs 2015 recommends HR-HPV-positive women should not be offered colposcopy immediately Triage should be done using cytology for this purpose If cytological abnormalities ASCUS are found immediate referral should follow for diagnosis and where appropriate treatment If no abnormalities are observed in triage the subject should be offered follow-up testing cytology at six months
There is no treatment that is recommended during this lap time The 2LPAPI has been available for more than 20 years and has received a marketing authorization in Belgium by the FAMHP It is used as an immune regulator in the treatment of HR-HPV infections Since 2LPAPI has been made available clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV
The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI on the clearance of genital HR-HPV infections
Detailed Description:
The study duration will be 48 months with 36 months of inclusion that may be extended if the expected number of patients is not reached after 36 months and 12 months of follow-up
Patients aged between 25 and 45 years who present cervical abnormalities during the routine screening visit for cervical cancer prevention
The total number of patients to include will be 284 with 142 patients per group
Primary objective
Comparison of the efficacy of 2LPAPI versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up
Secondary objectives
Comparison of 2LPAPI versus placebo on
HR-HPV infection clearance rate at 6-month visits
HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits
Normal cytology
Safety
Treatment phase
Group n1 2LPAPI 6 months of treatment Group n2 Placebo 6 months of treatment Post-treatment follow-up phase 6 months Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal
Patients aged between 25 and 45 years who present cervical abnormalities during the routine screening visit for cervical cancer prevention
The total number of patients to include will be 284 with 142 patients per group
Primary objective
Comparison of the efficacy of 2LPAPI versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up
Secondary objectives
Comparison of 2LPAPI versus placebo on
HR-HPV infection clearance rate at 6-month visits
HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits
Normal cytology
Safety
Treatment phase
Group n1 2LPAPI 6 months of treatment Group n2 Placebo 6 months of treatment Post-treatment follow-up phase 6 months Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None