Phase II AK Study in Organ Transplant Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Clinuvel Pharmaceuticals Limited.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Clinuvel Pharmaceuticals Limited
Information provided by:
Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00829192
First received: January 23, 2009
Last updated: December 3, 2010
Last verified: December 2010
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Purpose
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 |
|---|---|---|
|
Actinic Keratoses Carcinoma, Squamous Cell Organ Transplant Recipients |
Drug: Afamelanotide (CUV1647) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Further study details as provided by Clinuvel Pharmaceuticals Limited:
Primary Outcome Measures:
- 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:
- To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC) [ Time Frame: 24 months ]
- To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group [ Time Frame: 24 months ]
- To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) [ Time Frame: 24 months ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829192
Locations
| 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 | |
| Belgium | |
| Hospital Erasme | |
| Brussels, Belgium | |
| Gent University Hospital | |
| Gent, Belgium | |
| France | |
| University Hospital | |
| Besancon, France | |
| Germany | |
| Charité Univeritätsklinikum | |
| Berlin, Germany | |
| Kiel University Hospital | |
| Kiel, Germany | |
| Italy | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy | |
| University of Padua | |
| Padua, Italy | |
| Sweden | |
| Karolinska University Hospital | |
| Stockholm, Sweden | |
| Switzerland | |
| Universitätsspital Zürich | |
| Zürich, Switzerland | |
Sponsors and Collaborators
Clinuvel Pharmaceuticals Limited
Investigators
| Principal Investigator: | Günther Hofbauer, M.D. | Universitätsspital, Zürich |
More Information
No publications provided
| Responsible Party: | Dr Dennis Wright, Clinuvel Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00829192 History of Changes |
| Other Study ID Numbers: | CUV011 |
| Study First Received: | January 23, 2009 |
| Last Updated: | December 3, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Clinuvel Pharmaceuticals Limited:
|
Actinic keratoses (AK) Squamous cell carcinomas (SCC) CUV1647 Afamelanotide |
Clinuvel Photoprotection Organ transplant |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Keratosis Keratosis, Actinic Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Skin Diseases Precancerous Conditions Alpha-MSH Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013