Trial · NCT00979745
Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)
NCT00979745, Phase 3, Completed, Clinuvel Pharmaceuticals Limited; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP). Trials, record NCT00979745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00979745
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)
- NCT number
- NCT00979745
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 74 participants, actual
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Afamelanotide, Placebo
- First posted
- 2009-09-18
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0) | From baseline to Day 270 | |
| Secondary | Number of Phototoxic Reactions | 9 months | |
| Secondary | Quality of Life Measured by Patient Completed Questionnaire | 9 months | |
| Secondary | Free Protoporphyrin IX Level | 9 months | |
| Secondary | Treatment Emergent Adverse Events | 9 months |
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 | The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0) | From baseline to Day 270 | Hours | MEDIAN | |
| SECONDARY | Number of Phototoxic Reactions | 9 months | |||
| SECONDARY | Quality of Life Measured by Patient Completed Questionnaire | 9 months | |||
| SECONDARY | Free Protoporphyrin IX Level | 9 months | |||
| SECONDARY | Treatment Emergent Adverse Events | 9 months |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0) | Experimental: Afamelanotide | 6.0 | Full Range 0 to 192.5 | Hours | |
| The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0) | Placebo | 0.75 | Full Range 0 to 34.8 | Hours |
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 | Experimental: Afamelanotide | 38 | |
| Overall Study | STARTED | Placebo | 36 | |
| Overall Study | COMPLETED | Experimental: Afamelanotide | 34 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | Experimental: Afamelanotide | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events16
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 | Implant site discolouration | General disorders | Experimental: Afamelanotide | 4 | 38 | |
| other | Implant site discolouration | General disorders | Placebo | 0 | 36 | |
| other | Blood urine present | Investigations | Experimental: Afamelanotide | 2 | 38 | |
| other | Blood urine present | Investigations | Placebo | 2 | 36 | |
| other | Gamma-glutamyltransferase increased | Investigations | Experimental: Afamelanotide | 0 | 38 | |
| other | Gamma-glutamyltransferase increased | Investigations | Placebo | 3 | 36 | |
| other | Abdominal pain | Gastrointestinal disorders | Experimental: Afamelanotide | 2 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 36 | |
| other | Nausea | Gastrointestinal disorders | Experimental: Afamelanotide | 6 | 38 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 36 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Afamelanotide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Experimental: Afamelanotide | 16 | 38 |
| Total, other adverse events | Placebo | 12 | 36 |
| Total, serious adverse events | Experimental: Afamelanotide | 0 | 38 |
| Total, serious adverse events | Placebo | 0 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26132941 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Experimental: Afamelanotide vs Placebo: serious adverse events |
Source 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/NCT00979745
GET https://conductscience.org/api/trials/v1/NCT00979745/registered