NCT00829192

Phase II AK Study in Organ Transplant Patients

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Clinuvel Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses
• Carcinoma, Squamous Cell
• Organ Transplant Recipients

Interventions

Type	Name	Description
DRUG	Afamelanotide (CUV1647)	16 mg subcutaneous implant administered every 60 days
DRUG	Placebo	Placebo subcutaneous implant administered every 60 days

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2009-01-26
• Last updated: 2010-12-06

Locations

12 sites across 7 countries: Australia, Belgium, France, Germany, Italy, Sweden, Switzerland