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Sponsored by: |
Clinuvel Pharmaceuticals Limited |
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Information provided by: | Clinuvel Pharmaceuticals Limited |
ClinicalTrials.gov Identifier: | NCT00829192 |
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 |
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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. |
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 |
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1: Experimental
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
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Drug: Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days
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2: Placebo Comparator
Placebo implant administered subcutaneously every 60 days for 24 months
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Drug: Placebo
Placebo subcutaneous implant administered every 60 days
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Discontinuation Criteria:
Contact: Clinuvel Pharmaceuticals | +613 9660 4900 | clinicaltrials@clinuvel.com |
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 |
Principal Investigator: | Günther Hofbauer, M.D. | Universitätsspital, Zürich |
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 |
Actinic keratoses (AK) Squamous cell carcinomas (SCC) CUV1647 Afamelanotide |
Clinuvel Photoprotection Organ transplant |
Keratosis Skin Diseases Epidermoid Carcinoma Neoplasms, Squamous Cell Squamous Cell Carcinoma |
Carcinoma, Squamous Cell Tylosis Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Keratosis Skin Diseases |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |