Trial · NCT01573754
Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
NCT01573754, Phase 2, Completed, The University of Texas Medical Branch, Galveston; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda. Trials, record NCT01573754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01573754
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
- NCT number
- NCT01573754
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Porphyria Cutanea Tarda
- Interventions
- Hydroxychloroquine, Phlebotomy
- First posted
- 2012-04-09
- Last updated
- 2023-02-17
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Remission | To end of study, an average of 3 years | Time to a decrease in plasma porphyrin concentration to less than 0.9 mcg/dL |
| Secondary | 50% Reduction in Plasma Porphyrin Level | To end of study, an average of 3 years | 50% reduction in plasma porphyrin level during treatment |
| Secondary | 75% Reduction in Plasma Porphyrin Level | To end of study, an average of 3 years | Time to 75% reduction in plasma porphyrin level during treatment |
| Secondary | Number of Days With Normal Urinary Porphyrin Levels | To end of study, an average of 3 years | Number of days to normal urinary porphyrin levels for participants treated for Porphyria Cutanea Tarda (PCT). Days are summed together for all participants for a single value in each Arm. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Remission | To end of study, an average of 3 years | months | MEDIAN | |
| SECONDARY | 50% Reduction in Plasma Porphyrin Level | To end of study, an average of 3 years | Participants missed some study visits. | days | MEDIAN |
| SECONDARY | 75% Reduction in Plasma Porphyrin Level | To end of study, an average of 3 years | Participants missed some study visits. | days | MEDIAN |
| SECONDARY | Number of Days With Normal Urinary Porphyrin Levels | To end of study, an average of 3 years | days | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Remission | Hydroxychloroquine | 6.1 | Full Range 0.9 to 10.7 | months | |
| Remission | Phlebotomy | 6.9 | Full Range 1.8 to 26.5 | months | |
| 50% Reduction in Plasma Porphyrin Level | Hydroxychloroquine | 44 | Full Range 13 to 77 | days | |
| 50% Reduction in Plasma Porphyrin Level | Phlebotomy | 65 | Full Range 42 to 123 | days | |
| 75% Reduction in Plasma Porphyrin Level | Hydroxychloroquine | 73 | Full Range 72 to 123 | days | |
| 75% Reduction in Plasma Porphyrin Level | Phlebotomy | 44 | Full Range 40 to 238 | days | |
| Number of Days With Normal Urinary Porphyrin Levels | Hydroxychloroquine | 175 | days | ||
| Number of Days With Normal Urinary Porphyrin Levels | Phlebotomy | 265 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxychloroquine | 16 | |
| Overall Study | STARTED | Phlebotomy | 32 | |
| Overall Study | COMPLETED | Hydroxychloroquine | 13 | |
| Overall Study | COMPLETED | Phlebotomy | 17 | |
| Overall Study | NOT COMPLETED | Hydroxychloroquine | 3 | |
| Overall Study | NOT COMPLETED | Phlebotomy | 15 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| other | Suicidal thoughts | Psychiatric disorders | Hydroxychloroquine | 1 | 13 | 1 |
| other | Suicidal thoughts | Psychiatric disorders | Phlebotomy | 0 | 17 | 0 |
| other | Chest pain | General disorders | Hydroxychloroquine | 1 | 13 | 1 |
| other | Chest pain | General disorders | Phlebotomy | 0 | 17 | 0 |
| other | Pruritis | Skin and subcutaneous tissue disorders | Hydroxychloroquine | 1 | 13 | 1 |
| other | Pruritis | Skin and subcutaneous tissue disorders | Phlebotomy | 0 | 17 | 0 |
| serious | Death | General disorders | Hydroxychloroquine | 1 | 13 | 1 |
| serious | Death | General disorders | Phlebotomy | 0 | 17 | 0 |
| serious | Coronary disease | Cardiac disorders | Hydroxychloroquine | 2 | 13 | 2 |
| serious | Coronary disease | Cardiac disorders | Phlebotomy | 0 | 17 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxychloroquine | 1 | 13 |
| Total, all-cause mortality | Phlebotomy | 0 | 17 |
| Total, other adverse events | Hydroxychloroquine | 3 | 13 |
| Total, other adverse events | Phlebotomy | 0 | 17 |
| Total, serious adverse events | Hydroxychloroquine | 4 | 13 |
| Total, serious adverse events | Phlebotomy | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22985607 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD002604 | Hydroxychloroquine vs Phlebotomy for PCT | ANDERSON, KARL ELMO | UNIVERSITY OF TEXAS MED BR GALVESTON | FOOD AND DRUG ADMINISTRATION | 2005 to 2009 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hydroxychloroquine vs Phlebotomy: deaths from any cause | Trial comparisons |
| Hydroxychloroquine vs Phlebotomy: serious adverse events | Trial comparisons |
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/NCT01573754
GET https://conductscience.org/api/trials/v1/NCT01573754/registered