Status:
UNKNOWN
Phase II AK Study in Organ Transplant Patients
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Actinic Keratoses
Carcinoma, Squamous Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00829192
Start Date
November 1 2007
End Date
August 1 2012
Last Update
December 6 2010
Active Locations (12)
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1
The Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
2
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
3
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
4
Hospital Erasme
Brussels, Belgium