An observational study in Erythropoietic Protoporphyria (EPP) and X-Linked Porphyria (XLP), sponsored by Portal Therapeutics, Inc.. Recruiting at 19 sites in 9 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Portal Therapeutics, Inc. · Observational
The purpose of this study is to collect information about the effects of EPP/XLP in adults and adolescents. This is an observational study in which participants will not receive any treatment. Study details include:
29 studies on the registry are indexed under Protoporphyria, Erythropoietic; 5 are open to participants now.
Browse Protoporphyria, Erythropoietic studies →Portal Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study design and key inclusion criteria are focused on EPP/XLP and are inclusive of all potential participants, including those from underrepresented racial and ethnic populations. The sites and countries selected have diverse populations and the potential to enroll diverse participants.
Confirmed diagnosis of EPP or XLP as follows:
Exclusion Criteria:
Plasma Protoporphyrin IX (PPIX) Levels Over Time
Plasma protoporphyrin IX (PPIX) concentrations measured at specified study visits.
Time frame: Screening; Baseline; Weeks 4, 8, 12, 16, 20, 24
Clinical History of Phototoxic Symptoms and Prodrome Timing
Medical history of EPP/XLP symptoms, including time to onset of prodromal sensations and occurrence of phototoxic reactions.
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24
Skin Damage Manifestations
Skin damage manifestations associated with EPP/XLP, including swelling, erythema, and chronic skin changes.
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24
Light Exposure and Phototoxic Reaction Data From Daily Diary
Daily recorded light exposure (including time spent outdoors), light dosimetry measurements, and occurrence of phototoxic reactions as captured in participant diaries.
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24
Sunlight Exposure Required to Induce Prodromal Symptoms
Amount of sunlight exposure associated with onset of prodromal symptoms, along with corresponding plasma protoporphyrin IX (PPIX) levels.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20
Liver Function Test Results
Blood levels of liver function parameters (e.g., alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin) and corresponding plasma protoporphyrin IX (PPIX) levels.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24
Plan to share: Yes — What may be shared: De-identified individual participant data (no direct identifiers) Who can access it: Qualified researchers with a scientifically sound research proposal Conditions for access: Submission and approval of a research proposal Execution of a data sharing agreement (DSA) Compliance with privacy regulations (e.g., GDPR, HIPAA as applicable) How it will be shared: Through a secure data access process managed by the sponsor or designated data-sharing platform Timing: Typically after study completion and/or publication of primary results Purpose: To support further research on EPP and XLP while protecting participant confidentiality
No publications or documents are linked to this record.
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Portal Therapeutics, Inc.