Cincinnati, OHNCT07820085Now EnrollingIRB Ready

Erythropoietic Protoporphyria (EPP) Clinical Trial in Cincinnati, OH

Access cutting-edge erythropoietic protoporphyria (epp) treatment through this phase 2/3 clinical trial at a research site in Cincinnati. Study-provided care at no cost to qualified participants.

Sponsored by Portal Therapeutics, Inc.

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Expert Care in Cincinnati

Access erythropoietic protoporphyria (epp) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related erythropoietic protoporphyria (epp) treatment provided free

Apply for This Cincinnati Location

Check if you qualify for this erythropoietic protoporphyria (epp) clinical trial in Cincinnati, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cincinnati

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cincinnati site if eligible
  4. 4Begin participation

About This Erythropoietic Protoporphyria (EPP) Study in Cincinnati

PATHWAY is a Phase 2b/3 clinical study with an Open-Label Extension (OLE). It tests PORT-77 in patients with EPP, EPP2, and XLP. The study has three parts: Part 1: Phase 2b * Find the right dose of PORT-77 to lower PPIX levels in the blood * Test if PORT-77 lowers PPIX levels better than placebo * Check the safety of each dose Part 2: Phase 3 * Test if PORT-77 lowers PPIX levels better than placebo * Test if PORT-77 increases the amount of time patients spend in sunlight each day without pain compared to placebo * Check the safety of PORT-77 Part 3: Open-Label Extension (OLE) * Test the long-term effect of PORT-77 on PPIX levels and time in sun * Monitor long-term safety

Sponsor: Portal Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Aged 12 years or older.
Clinical history of EPP, XLP, or EPP2 supported by genetic confirmation or historical laboratory test results
History of consistent, non-painful prodrome within approximately 45 minutes of sunlight exposure and prior to phototoxic attacks
Demonstrates ≥85% compliance with daily symptom diary during run-in period.
Body weight or BMI at Screening as follows:
For participants aged 12 to \<18 years: body weight ≥32 kg
For participants aged ≥18 years: BMI ≥18.5 kg/m2
AST and ALT \<3 × ULN and total bilirubin \<2 × ULN (unless documented Gilbert syndrome) at Screening
Willing and able to provide informed consent and/or assent for the study.
Willing and able to comply with study visits, study procedures, and contraception guidance
Intends to remain in the same approximate geographic latitude for the duration of the placebo-controlled period, with no more than 14 days spent outside this region.

Exclusion Criteria

Diagnosis of another porphyria or another photodermatosis that may confound the evaluation of PORT-77
Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory assessments
Major surgery within 8 weeks before Screening, incomplete recovery from any previous surgery, or major surgery planned to occur during the study
History of, or anticipated need for, liver transplantation or history of bone marrow transplantation
Active infection with hepatitis B or C
Unable to swallow tablets or has a disease that significantly affects gastrointestinal function
Any other disease, condition, or circumstance that, at the discretion of the Investigator or Sponsor, would interfere with the evaluation of PORT-77 or study participation, or would make study participation not in the best interest of the participant
History of drug or alcohol abuse within the last 12 months, or current or planned use of prohibited or illegal substances
Has taken any medication, vitamin, or supplement that alters sensitivity to light exposure (eg, afamelanotide, melanotan, beta carotene, dersimelagon) within 90 days of Day 1; or has taken bitopertin within 120 days of Day 1; or has taken iron within 30 days of Day 1
Drugs or supplements that may impact or be impacted by PORT-77
Concurrent or anticipated participation in an interventional clinical trial during the study period.
Received another investigational therapy within 5 half-lives, if the half-life is known, or within 30 days, if the half-life is unknown, prior to Day 1.
Known hypersensitivity to PORT-77 or excipients
Female who has a positive pregnancy test at Screening or Day 1 or is breastfeeding

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT07820085) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Erythropoietic Protoporphyria (EPP) Treatment Options in Cincinnati, OH

If you're searching for erythropoietic protoporphyria (epp) treatment options in Cincinnati, OH, this clinical trial (NCT07820085) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced erythropoietic protoporphyria (epp) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all erythropoietic protoporphyria (epp) clinical trials near you to find additional studies recruiting in your area.

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