|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
4 April 2022 |
|
Main ID: |
EUCTR2008-002446-39-FR |
|
Date of registration:
|
25/08/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoing Photodynamic Therapy (PDT) utilising Porfimer Sodium - Phase II PDT Pilot Study
|
|
Scientific title:
|
A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoing Photodynamic Therapy (PDT) utilising Porfimer Sodium - Phase II PDT Pilot Study |
|
Date of first enrolment:
|
16/10/2008 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002446-39 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
• Male or female Caucasian subjects undergoing PDT with porfimer sodium.
• Aged greater than 18 years
• Fitzpatrick Skin Type I- IV
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Known allergy or hypersensitivity to CUV1647 or the polymer contained in the implant
Non-Caucasian patients
Personal history of melanoma or dysplastic nevus syndrome
Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions
Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating
Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device)
Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit
Patients unable to give informed consent
Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Barrett's Oesohagus
Cholangiocarcinoma
MedDRA version: 9.1
Level: LLT
Classification code 10004137
Term: Barrett's oesophagus
MedDRA version: 9.1
Level: LLT
Classification code 10008593
Term: Cholangiocarcinoma
|
|
Intervention(s)
|
Product Name: CUV1647 (Afamelanotide)
Product Code: CUV1647
Pharmaceutical Form: Implant
INN or Proposed INN: Afamelanotide
CAS Number: 75921-69-6
Current Sponsor code: CUV1647
Other descriptive name: NDP-alpha-MSH
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Subcutaneous use
|
|
Primary Outcome(s)
|
Primary end point(s): Primary Efficacy endpoint:
The first day on which patients are free from dermal symptoms following evaluation of photo toxicity
Primary Safety Endpoint:
Type and incidence of treatment emergent adverse events.
|
Secondary Objective: To evaluate the effect of CUV1647 treatment on the quality of life.
To evaluate the safety and tolerability of CUV1647 by measuring treatment-emergent adverse events.
|
|
Main Objective: To determine whether CUV1647 implants can reduce the period of phototoxicity experienced by patients who have undergone photodynamic therapy with porfimer sodium.
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 16/07/2008
Contact:
|
|