Erythropoietic Protoporphyria Clinical Trial
Official title:
Sorbent Therapy of the Cutaneous Porphyrias
Verified date | April 2013 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).
Status | Completed |
Enrollment | 4 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 22 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Adult over age 21 - healthy Exclusion Criteria: - Intercurrent illness - pregnancy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion of Second Treatment Phase | Subjects receive 1 gm colestipol twice daily for 90 days, and then 2 gm colestipol twice daily for 90 days. Treatment is stopped thereafter. | At end of 180 days of treatment | Yes |
Secondary | Completion of secondary treatment phase (Post Treatment) | Same as for the Primary Outcome Measure | 360 days | Yes |
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