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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00829192
Ethics application status
Date submitted
23/01/2009
Date registered
26/01/2009
Date last updated
6/12/2010

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
Other skin conditions
Cancer 0 0 0 0
Non melanoma skin cancer
Skin 0 0 0 0
Dermatological conditions

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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2012
Actual
Sample size
Target
200
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00829192