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Phase II AK Study in Organ Transplant Patients
This study is currently recruiting participants.
Verified by Clinuvel Pharmaceuticals Limited, April 2009
First Received: January 23, 2009   Last Updated: April 5, 2009   History of Changes
Sponsored by: Clinuvel Pharmaceuticals Limited
Information provided by: Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00829192
  Purpose

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.


Condition Intervention Phase
Actinic Keratoses
Carcinoma, Squamous Cell
Organ Transplant Recipients
Drug: Afamelanotide (CUV1647)
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Clinuvel Pharmaceuticals Limited:

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 [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC) [ Time Frame: 24 months ]
  • To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group [ Time Frame: 24 months ]
  • To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) [ Time Frame: 24 months ]

Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
Drug: Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days
2: Placebo Comparator
Placebo implant administered subcutaneously every 60 days for 24 months
Drug: Placebo
Placebo subcutaneous implant administered every 60 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829192

Contacts
Contact: Clinuvel Pharmaceuticals +613 9660 4900 clinicaltrials@clinuvel.com

Locations
Australia, Queensland
The Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Principal Investigator: Peter Soyer            
Sub-Investigator: Greg Siller            
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Adelaide, South Australia, Australia, 5011
Principal Investigator: Warren Weightman            
Australia, Victoria
The Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia
Principal Investigator: George Varigos            
Belgium
Hospital Erasme Not yet recruiting
Brussels, Belgium
Principal Investigator: Veronique Del Marmol            
Gent University Hospital Not yet recruiting
Gent, Belgium
Principal Investigator: Lieve Brochez            
France
University Hospital Recruiting
Besancon, France
Principal Investigator: Francois Aubin            
Germany
Charité Univeritätsklinikum Not yet recruiting
Berlin, Germany
Principal Investigator: Susanne Astner            
Kiel University Hospital Not yet recruiting
Kiel, Germany
Principal Investigator: Michael Weichenthal            
Italy
University of Padua Not yet recruiting
Padua, Italy
Principal Investigator: Stefano Piaserico            
Ospedali Riuniti di Bergamo Recruiting
Bergamo, Italy
Principal Investigator: Luigi Naldi            
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Principal Investigator: Bernt Lindelöf            
Switzerland
Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland
Principal Investigator: Günther Hofbauer            
Sponsors and Collaborators
Clinuvel Pharmaceuticals Limited
Investigators
Principal Investigator: Günther Hofbauer, M.D. Universitätsspital, Zürich
  More Information

No publications provided

Responsible Party: Clinuvel Pharmaceuticals ( Dr Dennis Wright )
Study ID Numbers: CUV011
Study First Received: January 23, 2009
Last Updated: April 5, 2009
ClinicalTrials.gov Identifier: NCT00829192     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Clinuvel Pharmaceuticals Limited:
Actinic keratoses (AK)
Squamous cell carcinomas (SCC)
CUV1647
Afamelanotide
Clinuvel
Photoprotection
Organ transplant

Study placed in the following topic categories:
Keratosis
Skin Diseases
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Tylosis
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Keratosis
Skin Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009