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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 081973
ACTR Number: ACTRN12607000261415
Trial Status: Registered
Date Submitted: 19/04/2007
Date Registered: 15/05/2007

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Public title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)
ANZCTR registration title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Erythropoietic Protoporphyria 
Condition category: Condition code:
Human genetics and inherited disorders Other human genetics and inherited disorders 

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Description of intervention(s) / exposure: CUV1647 (16 mg/implant) contained in a poly(D,L-lactide-co-glycolide) implant core. The implant is fully bioresorbable and implanted subcutaneously. Drug is released from the active implant over 10 to 15 days. The study design consists of two parallel study arms with crossover between treatments every 60 days for 360 days. There is no wash out period in this study.
Intervention code:Treatment: drugs 
Comparator / control treatment: Placebo poly(D,L-lactide-co-glycolide) implant (without drug).
Control group: Placebo

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Primary outcome 1:Determine whether CUV1647 can reduce the number of phototoxic reactions in patients with EPP 
Timepoint:Patients record the number of reactions in a diary card completed every day and assessed every 30 days. 
Primary outcome 2:Determine whether CUV1647 can reduce the severity of phototoxic reactions in patients with EPP 
Timepoint:Patients record the severity of reactions in a diary card completed every day and assessed every 30 days. 
Secondary outcome 1:Determine whether CUV1647 can increase the duration of sunlight tolerated by EPP patients. 
Timepoint:Patients record the amount of time spent in sunlight in the diary card which is completed every day and reviewed every 30 days. 
Secondary outcome 2:Determine whether CUV1647 increases melanin density in the skin at specified body sites. 
Timepoint:Melanin density is measured every 30 days. 
Secondary outcome 3:Evaluate the safety and tolerability of CUV1647 by measuring treatment-emergent adverse events (TEAEs). 
Timepoint:TEAEs will be recorded daily in the patient diary card and assesed every 30 days. 
Secondary outcome 4:Determine whether CUV1647 can improve the quality of life (QoL) of EPP patients. 
Timepoint:QoL is measured with the SF36 v2 questionnaire every 60 days. 

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Key inclusion criteria: Subjects with a positive diagnosis of EPP
Minimum Age: 18 Years
Maximum Age: 70 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: EPP patients with significant hepatic involvement Any other photodermatosis

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Central randomisation by computer
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Stratified by centre, simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation).
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people receiving the treatment/s
 The people administering the treatment/s
Assignment: Parallel
Other design features (specify): The study is blinded to both treating doctor and patient. The study design consists of two parallel study arms with crossover between treatments every 60 days
Type of endpoint(s): Safety/efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 1/06/2007
Target sample size: 70
Recruitment status: Closed: follow-up continuing

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Funding source:Commercial sector/Industry 
Name:Clinuvel Pharmaceuticals Limited 
Address:11/330 Collins St Melbourne VIC 3000 
Country:Australia 
Primary sponsor: Commercial sector/Industry
Name: Clinuvel Pharmaceuticals Limited
Address: 11/330 Collins St Melbourne VIC 3000
Country: Australia
Secondary sponsor:None 
Name:nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Ethik-Kommission der beiden Stadtspitaler Triemli und Waid Zuerich 
Address: 
Country:Switzerland 
Date of approval: 
HREC Number:STZ 07/07 
Ethics Committee name 2:Melbourne Health Human Research Ethics Committee 
Address:Research Directorate Level 6 East, Main Block Royal Melbourne Hospital City Campus Grattan Street PARKVILLE VIC 3050 
Country:Australia 
Date of approval:18/07/2007 
HREC Number:EC00243 
Ethics Committee name 3:Comite de Protection des Personnes Ile de France VIII 
Address:Hospital Ambroise Pare 9, avenue Charles de Gaulle 92100 Boulogne-Billancourt 
Country:France 
Date of approval:24/04/2008 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 4:Comitato Etico I.F.O. 
Address:via Chianesi, 53 00128 Roma 
Country:Italy 
Date of approval:30/07/2007 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 5:Ethikkommission an der Med. Fakultat der Heinrich-Heine-Univ. Duesseldorf 
Address:Kinderklinik Geb. 13.41 Moorenstr. 5 40225 Duesseldorf 
Country:Germany 
Date of approval:2/06/2008 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 6:Regionala etikprovningsnamnden i Stockholm 
Address:FE 289 Stockholm 171 77 
Country:Sweden 
Date of approval:7/05/2008 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 7:Multi-centre Research Ethics Committee for Wales 
Address:4th Floor, Churchill House Churchill Way Cardiff CF10 2TW 
Country:United Kingdom 
Date of approval:17/06/2008 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 8:Medisch Ethische Toetsings Commissie Erasmus MC 
Address:Erasmus MC/faculteit, Kamer Fd-209, Postbus 2040, 3000 CA ROTTERDAM 
Country:Netherlands 
Date of approval:18/09/2008 
HREC Number:New ethics HREC. Please modify. 
Countries of recruitment:Australia 
Postcode:3000 
Outside Australia 
Germany - Duesseldorf 
Sweden - Stockholm 
France - Paris 
Italy - Rome 
Brief summary: The purpose of this study is to determine if there is a difference between the number and severity of phototoxic reactions that occurr in patients with Erythropoietic Protoporphyria (EPP) treated with CUV1647 and placebo.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dennis Wright
Address: Clinuvel Pharmaceuticals Limited 11/330 Collins St Melbourne VIC 3000
Country: Australia
Tel: +61 3 96604900
Fax:
Email: clinicaltrials@clinuvel.com

Contact person for scientific queries
Name: Dennis Wright
Address: Clinuvel Pharmaceuticals Limited 11/330 Collins St Melbourne VIC 3000
Country: Australia
Tel: +61 3 96604900
Fax:
Email: clinicaltrials@clinuvel.com

Contact person responsible for updating information
Name: Jessica Jia
Address: Clinuvel Pharmaceuticals Limited 11/330 Collins St Melbourne VIC 3000
Country: Australia
Tel: +61 3 9660 4900
Fax: +61 3 9660 4999
Email: clinicaltrials@clinuvel.com
   
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