Clinical trial NCT00829192: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Actinic Keratoses
Carcinoma, Squamous Cell
Organ Transplant Recipients
Keywords: Actinic keratoses (AK)
Squamous cell carcinomas (SCC)
CUV1647
Afamelanotide
Clinuvel
Photoprotection
Organ transplant
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: 24 months
Secondary outcomes:
measure: To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
timeFrame: 24 months
measure: To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
timeFrame: 24 months
measure: To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
timeFrame: 24 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Gent
country: Belgium
facility: Gent University Hospital
city: Besancon
country: France
facility: University Hospital
city: Berlin
country: Germany
facility: Charité Univeritätsklinikum
city: Kiel
country: Germany
facility: Kiel University Hospital
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Padua
country: Italy
facility: University of Padua
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätsspital Zürich
name: Günther Hofbauer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: