Trial · NCT01422915
Sorbent Therapy of the Cutaneous Porphyrias
NCT01422915, Phase 2, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2017-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sorbent Therapy of the Cutaneous Porphyrias. Trials, record NCT01422915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01422915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorbent Therapy of the Cutaneous Porphyrias
- NCT number
- NCT01422915
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Colestipol
- First posted
- 2011-08-25
- Last updated
- 2017-04-25
- Results first posted
- 2017-04-25
- Limitations and caveats
- 1 subject was removed during Period 1 because of abnormal liver chemistries.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance | At 60 days of treatment | Minutes of sun tolerance |
| Primary | Protoporphyrin Concentration in Blood | Samples collected while on treatment (range 93-208 treatment days) | 1. erythrocyte protoporphyrin concentration, ug/dl 2. plasma protoporphyrin concentration, ug/dl |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance | At 60 days of treatment | All of the original 4 subjects had bona fide erythropoietic protoporphyria (EPP). One subject was removed during Perdiod 1. The data from the same 3 subjects who completed periods 1 and 2 were analyzed for the study results. Data collected was not tractable for statistical analysis given the range of results | minutes | MEAN |
| PRIMARY | Protoporphyrin Concentration in Blood | Samples collected while on treatment (range 93-208 treatment days) | ug/dl | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance | Colestipol Treatment | 65.8 | Standard Deviation 58.8 | minutes | |
| Protoporphyrin Concentration in Blood | Colestipol Treatment | Erythrocyte Protoporphyrin | 1712 | Standard Deviation 455 | ug/dl |
| Protoporphyrin Concentration in Blood | Colestipol Treatment | Plasma Protoporphyrin | 5.8 | Standard Deviation 8.3 | ug/dl |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colestipol Treatment | 4 | |
| Overall Study | COMPLETED | Colestipol Treatment | 3 | |
| Overall Study | NOT COMPLETED | Colestipol Treatment | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abnormal liver enzymes | Hepatobiliary disorders | 1st Period - Colestipol Optimal Dosage | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1st Period - Colestipol Optimal Dosage | ||
| Total, other adverse events | 1st Period - Colestipol Optimal Dosage | 0 | 4 |
| Total, serious adverse events | 1st Period - Colestipol Optimal Dosage | 1 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01422915
GET https://conductscience.org/api/trials/v1/NCT01422915/registered