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Phase II AK Study in Organ Transplant Patients

Primary Purpose

Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Afamelanotide (CUV1647)
Placebo
Sponsored by
Clinuvel Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Actinic Keratoses focused on measuring Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry
  • Organ transplant patients who have had at least one biopsy-positive SCC
  • Aged 18 - 75 years
  • Written informed consent to the performance of all study-specific procedures

Exclusion Criteria:

  • Allergy to afamelanotide (CUV1647) or the polymer contained in the implant
  • History of melanoma
  • Current pigmentary disorders such as melasma
  • Diagnosed with HIV/AIDS, or hepatitis B or C
  • Current history of drug or alcohol abuse (in the last 12 months)
  • Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures
  • Major medical or psychiatric illness
  • Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers
  • Females of child bearing potential not using adequate contraceptive measures
  • Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
  • Use of regular medications or any other factors that may affect skin pigmentation

Discontinuation Criteria:

  • Initiation of treatment with systemic retinoids
  • Change of class of systemic immunosuppressant treatment

Sites / Locations

  • The Princess Alexandra Hospital
  • The Queen Elizabeth Hospital
  • The Royal Melbourne Hospital
  • Hospital Erasme
  • Gent University Hospital
  • University Hospital
  • Charité Univeritätsklinikum
  • Kiel University Hospital
  • Ospedali Riuniti di Bergamo
  • University of Padua
  • Karolinska University Hospital
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

Placebo implant administered subcutaneously every 60 days for 24 months

Outcomes

Primary Outcome Measures

To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands

Secondary Outcome Measures

To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)

Full Information

First Posted
January 23, 2009
Last Updated
December 3, 2010
Sponsor
Clinuvel Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00829192
Brief Title
Phase II AK Study in Organ Transplant Patients
Official Title
A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Clinuvel Pharmaceuticals Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients
Keywords
Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo implant administered subcutaneously every 60 days for 24 months
Intervention Type
Drug
Intervention Name(s)
Afamelanotide (CUV1647)
Intervention Description
16 mg subcutaneous implant administered every 60 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous implant administered every 60 days
Primary Outcome Measure Information:
Title
To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands
Time Frame
24 months
Secondary Outcome Measure Information:
Title
To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
Time Frame
24 months
Title
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
Time Frame
24 months
Title
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry Organ transplant patients who have had at least one biopsy-positive SCC Aged 18 - 75 years Written informed consent to the performance of all study-specific procedures Exclusion Criteria: Allergy to afamelanotide (CUV1647) or the polymer contained in the implant History of melanoma Current pigmentary disorders such as melasma Diagnosed with HIV/AIDS, or hepatitis B or C Current history of drug or alcohol abuse (in the last 12 months) Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures Major medical or psychiatric illness Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers Females of child bearing potential not using adequate contraceptive measures Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit Use of regular medications or any other factors that may affect skin pigmentation Discontinuation Criteria: Initiation of treatment with systemic retinoids Change of class of systemic immunosuppressant treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günther Hofbauer, M.D.
Organizational Affiliation
Universitätsspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Hospital Erasme
City
Brussels
Country
Belgium
Facility Name
Gent University Hospital
City
Gent
Country
Belgium
Facility Name
University Hospital
City
Besancon
Country
France
Facility Name
Charité Univeritätsklinikum
City
Berlin
Country
Germany
Facility Name
Kiel University Hospital
City
Kiel
Country
Germany
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
University of Padua
City
Padua
Country
Italy
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Universitätsspital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

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Phase II AK Study in Organ Transplant Patients

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