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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. |
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Register:
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EUCTR |
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Last refreshed on:
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26 November 2018 |
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Main ID: |
EUCTR2007-002863-28-GB |
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Date of registration:
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15/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Investigation into the use of colestyramine as a therapy for patients with erythropoietic protoporphyria - EPP001
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Scientific title:
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Investigation into the use of colestyramine as a therapy for patients with erythropoietic protoporphyria - EPP001 |
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Date of first enrolment:
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26/09/2007 |
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Target sample size:
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21 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002863-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: treatment versus no-treatment within each subject
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: No treatment
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients who regularly attend the Photodermatoses clinic at St Thomas’ Hospital and meet the inclusion criteria below will be invited to participate in this trial: -
•Patients with a diagnosis of EPP.
•Patients aged 18 years or over.
•Patients who are willing and able to give written informed consent to participate in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
•Patients under 18 years of age
•Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs and unable to give informed consent.
•Patients who are pregnant or breast feeding.
•Patients who are unwilling or unable to comply with the study protocol
•Patients with complete biliary obstruction
•Patients who have diabetes mellitus
•Patients with epilepsy
•Patients prescribed thyroxine sodium for hypothyroidism
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Erythropoietic protoporphyria (EPP)
MedDRA version: 9.1
Level: LLT
Classification code 10015289
Term: Erythropoietic protoporphyria
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Intervention(s)
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Trade Name: Questran
Product Name: Questran
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: COLESTYRAMINE
CAS Number: 11041126
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 4-
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Primary Outcome(s)
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Primary end point(s): Does colestyramine decrease the plasma and red cell protoporphyrin concentration by at least 15% in EPP (15% chosen because it is the level below which a fall in plasma and red cell protoporphyrin is not likely to be clinically significant in terms of symptom control).
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Secondary Objective: None
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Main Objective: Erythropoietic protoporphyria (EPP) is an inherited disease in which protoporphyrin accumulates in red blood cells and causes 2-3 day long bouts of severe pain following exposure of the skin to sunlight. It is a lifelong, severe and disabling condition for which there is no effective treatment.
Colestyramine is an anion-exchange resin. It has been shown to bind to protoporphyrin (Stathers, 1966) in the gut and to increase its faecal excretion (McCullough et al., 1988; Bloomer, 1979) (by interrupting the porphyrin's enterohepatic recirculation).
The main objective of this trial is to assess whether oral colestyramine is likely to be a useful therapy in EPP, by seeing whether it reduces the plasma and red cell protoporphyrin concentration in EPP patients when given over a three month period.
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Secondary ID(s)
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EPP001
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n/a
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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