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Phase II AK Study in Organ Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829192
Recruitment Status : Unknown
Verified December 2010 by Clinuvel Pharmaceuticals Limited.
Recruitment status was:  Active, not recruiting
First Posted : January 26, 2009
Last Update Posted : December 6, 2010
Information provided by:
Clinuvel Pharmaceuticals Limited

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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Carcinoma, Squamous Cell Organ Transplant Recipients Drug: Afamelanotide (CUV1647) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : November 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: 1
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
Drug: Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days

Placebo Comparator: 2
Placebo implant administered subcutaneously every 60 days for 24 months
Drug: Placebo
Placebo subcutaneous implant administered every 60 days

Primary Outcome Measures :
  1. 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 :
  1. To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC) [ Time Frame: 24 months ]
  2. To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group [ Time Frame: 24 months ]
  3. To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829192

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Australia, Queensland
The Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, South Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Australia, Victoria
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
Sponsors and Collaborators
Clinuvel Pharmaceuticals Limited
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Principal Investigator: Günther Hofbauer, M.D. Universitätsspital Zürich

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Responsible Party: Dr Dennis Wright, Clinuvel Pharmaceuticals Identifier: NCT00829192    
Other Study ID Numbers: CUV011
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010
Keywords provided by Clinuvel Pharmaceuticals Limited:
Actinic keratoses (AK)
Squamous cell carcinomas (SCC)
Organ transplant
Additional relevant MeSH terms:
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Keratosis, Actinic
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Skin Diseases
Precancerous Conditions
Neoplasms, Squamous Cell
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs