Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM... | NCT03289260

Studies
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

NCT03289260

Sponsor

Medical University Innsbruck

Status

Unknown status

Last Update Posted

Sep 23, 2020Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Anogenital Human Papillomavirus Infection
Condyloma Anal

Interventions

Imiquimod 5% cream
Placebo cream
Fulguration

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2021Estimated

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

Nov 15, 2024Estimated

First Submitted Date

Sep 19, 2017

First Submission Date that Met QC Criteria

Sep 19, 2017

First Posted Date

Sep 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2020

Last Update Posted Date

Sep 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Irmgard E Kronberger, MD, Leading Consultent, Medical University InnsbruckPrincipal Investigator

Lead Sponsor

Medical University InnsbruckOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.

Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.

100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional Arm	Experimental	Imiquimod 5% cream therapy Fulguration	Drug: Imiquimod 5% cream Procedure: Fulguration
Placebo Arm	Placebo Comparator	Placebo cream therapy Fulguration	Drug: Placebo cream Procedure: Fulguration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod 5% cream	Drug	Patients receive topical Imiquimod therapy for 12 weeks.	Interventional Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in recurrence rates between the two arms	Recurrence is evaluated by clinical examination (proctoscopy)	12 months

Secondary Outcomes

Measure	Description	Time Frame
CD4 (cluster of differentiation 4) cell count	Influence of CD4 cell count in the subgroup of HIV positive patients	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand and willingness to sign and date a written consent document
Male and female patients >= 18 years of age
Negative urine/serum pregnancy test
Indication for surgical therapy of anal HPV lesions

Exclusion Criteria:

Participation in another clinical study with experimental therapy
Diagnosis and therapy of HPV associated lesions in the last 12 months
Known intolerance of hypersensitivity to Imiquimod
Women who are pregnant of lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Irmgard E Kronberger, MD	Contact	0043512504	80823	irmgard.kronberger@i-med.ac.at
Sascha Czipin, MD	Contact	0043512504	82070	sascha.czipin@i-med.ac.at

Overall Officials

Name	Affiliation	Role
Dietmar Öfner-Velano, MD	University Hospital for Visceral, Transplant and Thoracic Surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Visceral-, Transplant- and Thoracic Surgery		Innsbruck	Tyrol	6020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003218	Condylomata Acuminata

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod
D003972	Diathermy

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided