Phase 3 N=4 Treatment

Sorbent Therapy of the Cutaneous Porphyrias

Erythropoietic Protoporphyria

Bottom Line

View on ClinicalTrials.gov: NCT01422915 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Apr 2017

Primary outcome: Primary: Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance — 65.8 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Colestipol (Drug)
Age: Adult · 22+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance	65.8	—
PRIMARY Protoporphyrin Concentration in Blood	1712; 5.8	—

Summary

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 reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Eligibility Criteria

Inclusion Criteria

Adult over age 21
healthy

Exclusion Criteria

Intercurrent illness
pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01422915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.