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Investigation into the use of colestyramine as a therapy for patients with erythropoietic protoporphyria - EPP001

Phase 1
Conditions
Erythropoietic protoporphyria (EPP)
MedDRA version: 9.1Level: LLTClassification code 10015289Term: Erythropoietic protoporphyria
Registration Number
EUCTR2007-002863-28-GB
Lead Sponsor
Guy's & St Thomas' NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
21
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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