Trial · NCT02180412
Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
NCT02180412, Phase 2, Completed, The University of Texas Medical Branch, Galveston; results first posted 2025-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria. Trials, record NCT02180412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
- NCT number
- NCT02180412
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Acute Porphyrias
- Interventions
- Panhematin, Glucose
- First posted
- 2014-07-02
- Last updated
- 2025-04-11
- Results first posted
- 2025-04-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in NRS Pain Score Between Baseline and 12 Hours | Baseline and 12 hours | The difference in the pre-infusion NRS pain scores and NRS pain score 12 hours from the infusion start time. To define this variable, all blinded study treatment infusion times were compared with the pain score survey times. The pain score closest to but prior to the infusion time was the pre-infusion pain score. Numeric rating scale for pain (0-10; 0=no pain, 10=most severe pain). |
| Secondary | Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Day 1 (baseline), Day 2, Day 3 and Day 4 | Difference in the panhematin and placebo arm for the change in urinary ALA, (PBG), and total porphyrins between baseline and subsequent time points. |
| Other | Effects of Clinical Features on Response to Panhematin | 4 days | Age, sex, exacerbating factors |
| Other | Effects of Genetic Features on Response to Panhematin | 4 days | Types of mutations |
| Other | Use of Reconstitution of Panhematin With Albumin | 4 days | Frequency of side effects or adverse events |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in NRS Pain Score Between Baseline and 12 Hours | Baseline and 12 hours | One participant was randomized incorrectly and didn't meet inclusion criteria. Therefore, this analysis was done without one participant, making this analysis done under modified intent-to-treat protocol, not true intent-to-treat protocol. | score on a scale | MEAN |
| SECONDARY | Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Day 1 (baseline), Day 2, Day 3 and Day 4 | One participant was randomized incorrectly and didn't meet inclusion criteria. Therefore, this analysis was done without one participant, making this analysis done under modified intent-to-treat protocol, not true intent-to-treat protocol. | mean difference of mg/g creatinine | MEAN |
| OTHER_PRE_SPECIFIED | Effects of Clinical Features on Response to Panhematin | 4 days | |||
| OTHER_PRE_SPECIFIED | Effects of Genetic Features on Response to Panhematin | 4 days | |||
| OTHER_PRE_SPECIFIED | Use of Reconstitution of Panhematin With Albumin | 4 days |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in NRS Pain Score Between Baseline and 12 Hours | Panhematin | -0.2 | Standard Deviation 2.2 | score on a scale | |
| Difference in NRS Pain Score Between Baseline and 12 Hours | Placebo | -0.2 | Standard Deviation 1.9 | score on a scale | |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Panhematin | ALA Day 1 vs Day 2 | 8.47 | Standard Deviation 8.97 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Placebo | ALA Day 1 vs Day 2 | 2.31 | Standard Deviation 5.5 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Panhematin | ALA Day 1 vs Day 3 | 13.27 | Standard Deviation 11.45 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Placebo | ALA Day 1 vs Day 3 | -0.57 | Standard Deviation 6.01 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Panhematin | ALA Day 1 vs Day 4 | 14.90 | Standard Deviation 11.85 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Placebo | ALA Day 1 vs Day 4 | 1.99 | Standard Deviation 10.73 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Panhematin | PBG Day 1 vs Day 2 | 6.56 | Standard Deviation 11.69 | mean difference of mg/g creatinine |
| Biochemical Effects of Panhematin In Participants Treated Early For Attacks of Porphyria | Placebo | PBG Day 1 vs Day 2 | -2.94 | Standard Deviation 12.85 | mean difference of mg/g creatinine |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panhematin | 10 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | Panhematin | 10 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Panhematin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panhematin | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | Panhematin | 0 | 10 |
| Total, other adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | Panhematin | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42833135 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Panhematin vs Placebo: deaths from any cause | Trial comparisons |
| Panhematin vs Placebo: 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/NCT02180412
GET https://conductscience.org/api/trials/v1/NCT02180412/registered