HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP
Public ClinicalTrials.gov record NCT05883748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
Study identification
- NCT ID
- NCT05883748
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2023 (Actual)
- Primary completion
- Jun 2028 (Estimated)
- Completion
- Jun 2028 (Estimated)
- Last update posted
- Oct 9, 2026
2023 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | 35233 | — |
| University of California San Francisco | San Francisco | California | 94117 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| MetroBoston Clinical Partners | Boston | Massachusetts | 02135 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| University of Texas | Galveston | Texas | 77550 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05883748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05883748 live on ClinicalTrials.gov.