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Phase II AK Study in Organ Transplant Patients

NCT00829192 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-12-06

No results posted yet for this study

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

DRUG

Afamelanotide (CUV1647)

16 mg subcutaneous implant administered every 60 days

DRUG

Placebo

Placebo subcutaneous implant administered every 60 days

Sponsors & Collaborators

  • Clinuvel Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Günther Hofbauer, M.D. · Universitätsspital Zürich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Australia
  • Belgium
  • France
  • Germany
  • Italy
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00829192 on ClinicalTrials.gov