CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4 enrolled
Drug / intervention
Colestipoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01422915
NCT01422915Phase 3Completed
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Sorbent Therapy of the Cutaneous Porphyrias

Brigham and Women's Hospital·interventional·Posted Aug 25, 2011·Updated Apr 25, 2017

In Brief

A Phase 3 clinical trial evaluating Colestipol for Erythropoietic Protoporphyria. Completed, enrolled 4 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythropoietic Protoporphyria
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.9 years ago

Interventions

Colestipoldrug

2 grams morning and bedtime for 90 days.