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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 ID: NCT00829192
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Princess Alexandra Hospital, Brisbane, Queensland, Australia
The Queen Elizabeth Hospital, Adelaide, South Australia, Australia
The Royal Melbourne Hospital, Melbourne, Victoria, Australia
Hospital Erasme, Brussels, , Belgium
Gent University Hospital, Gent, , Belgium
University Hospital, Besancon, , France
Charité Univeritätsklinikum, Berlin, , Germany
Kiel University Hospital, Kiel, , Germany
Ospedali Riuniti di Bergamo, Bergamo, , Italy
University of Padua, Padua, , Italy
Karolinska University Hospital, Stockholm, , Sweden
Universitätsspital Zürich, Zürich, , Switzerland
Name: Günther Hofbauer, M.D.
Affiliation: Universitätsspital Zürich
Role: PRINCIPAL_INVESTIGATOR