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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00829192




Registration number
NCT00829192
Ethics application status
Date submitted
23/01/2009
Date registered
23/01/2009
Date last updated
3/12/2010

Titles & IDs
Public title
Phase II AK Study in Organ Transplant Patients
Scientific 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.
Secondary ID [1] 0 0
CUV011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratoses 0 0
Carcinoma, Squamous Cell 0 0
Organ Transplant Recipients 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Afamelanotide (CUV1647)
Treatment: Drugs - Placebo

Experimental: 1 - Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

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


Treatment: Drugs: Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days

Treatment: Drugs: Placebo
Placebo subcutaneous implant administered every 60 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
Timepoint [3] 0 0
24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
France
State/province [3] 0 0
Besancon
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Kiel
Country [6] 0 0
Italy
State/province [6] 0 0
Bergamo
Country [7] 0 0
Italy
State/province [7] 0 0
Padua
Country [8] 0 0
Sweden
State/province [8] 0 0
Stockholm
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clinuvel Pharmaceuticals Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00829192
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Günther Hofbauer, M.D.
Address 0 0
Universitätsspital Zürich
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00829192