Phase 3
Completed N=4
Sorbent Therapy of the Cutaneous Porphyrias
Source: ClinicalTrials.gov NCT01422915 ↗Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Apr 2017
Primary outcomePrimary: Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance — 65.8 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
Eligibility Criteria
Inclusion Criteria
- Adult over age 21
- healthy
Exclusion Criteria
- Intercurrent illness
- pregnancy
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. Informational only — not medical advice.