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Trial · Interventional

Status unknownPhase 2Registry data

Phase II AK Study in Organ Transplant Patients

NCTNCT00829192 (opens ClinicalTrials.gov in a new tab)Other idCUV011
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
200 participants (estimated)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Randomized · Double masking
Countries
7 countries

Australia, Belgium, France, Germany, Italy, Sweden, Switzerland

Start
Nov 2007
Primary completion
Jul 2012 (estimated)
Completion
Aug 2012 (estimated)
First posted
26 Jan 2009 (estimated)
Last update posted
6 Dec 2010 (estimated)
Conditions
Actinic Keratoses · Carcinoma, Squamous Cell · Organ Transplant Recipients

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010201120122013
  1. Ph 2

    Phase II AK Study in Organ Transplant Patients

    NCT00829192

    Nov 2007 to est. Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Afamelanotide (CUV1647)Drug
  • PlaceboDrug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(3)

  1. To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)

    Time frame · 24 months

  2. To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group

    Time frame · 24 months

  3. To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)

    Time frame · 24 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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