Cleveland, OHNCT07024316Now EnrollingIRB Ready

Congenital Erythropoietic Porphyria (CEP) Clinical Trial in Cleveland, OH

Access cutting-edge congenital erythropoietic porphyria (cep) treatment through this clinical trial at a research site in Cleveland. Study-provided care at no cost to qualified participants.

Sponsored by Atlas Molecular Pharma

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Expert Care in Cleveland

Access congenital erythropoietic porphyria (cep) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related congenital erythropoietic porphyria (cep) treatment provided free

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Check if you qualify for this congenital erythropoietic porphyria (cep) clinical trial in Cleveland, OH

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Why Participate?

  • No-Cost Study Care

  • Local to Cleveland

    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 Cleveland site if eligible
  4. 4Begin participation

About This Congenital Erythropoietic Porphyria (CEP) Study in Cleveland

This is a study to investigate the effect of oral ATL-001 (ciclopirox) in CEP (Congenital Erythropoietic Porphyria) patients. During the study, it will be measured the improvement of skin lesions, fatigue and other clinical symptoms as well as blood parameters. Funding source - FDA OOPD

Sponsor: Atlas Molecular Pharma

Who Can Participate

Inclusion Criteria

Aged 18 years or older at the time of signing the informed consent form (ICF)
Diagnosis of CEP, based on medical history and/or biochemical porphyrin analysis. Sponsor will review the CEP diagnostic criteria (medical history or biochemical porphyrin analysis) of each potential patient, written Sponsor approval before starting the run-in period will be required
a) Female participants must not be pregnant or lactating at screening or admission 3\. b) Female participants must be of nonchildbearing potential or agree to use 2 adequate forms of highly effective method(s) of contraception throughout the entire duration of study participation and for at least 4 weeks after the last dose of any study intervention and have negative pregnancy test results at screening (serum) and admission (urine) 4. Male participants with female partners of childbearing potential must be surgically sterile (successful vasectomy at least 4 weeks prior to Day 1) or agree to use adequate forms of highly effective contraception (together with their female partner) for the duration of the study and for at least 4 weeks after the last dose of study intervention; must also agree to refrain from sperm donation during the study and for at least 4 weeks after the last dose of study intervention 5. Negative pregnancy test (females of childbearing potential) at Screening (Month -6), at Baseline (Day 1) and at every visit site until EoS prior to dosing 6. Able to understand the study aims, procedures, and requirements, and provide written informed consent 7. Able to comply with all study procedures 8. Able and committed to complete study patient diaries and questionnaires

Exclusion Criteria

Other than CEP, an inherited or acquired red cell disease associated with anemia
Any other photodermatosis such as solar urticaria
A history or known allergic reaction to any investigational product excipients or the investigational drug
Major surgery within 8 weeks before Screening, incomplete recovery from any previous surgery or planned major surgery during the study
History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator
Human immunodeficiency virus (HIV), active Hepatitis B, or C. A positive hepatitis result should be discussed between the Investigator and Sponsor prior to enrolment
Score of Personal Health Questionnaire Depression Scale (PHQ-8) ≥10 at screening or any response of "yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Uncontrolled medical condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months
Administration of afamelanotide and dersimelagon within the last 2 months prior to start of the run-in period
Total bilirubin \>2× ULN (unless documented Gilbert syndrome) at Screening
If female, pregnant or breastfeeding. Final\_V2.1 38 of 106 11 Apr 2025
Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening.

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 Cleveland?

Yes, this clinical trial (NCT07024316) has an active research site in Cleveland, 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.

Congenital Erythropoietic Porphyria (CEP) Treatment Options in Cleveland, OH

If you're searching for congenital erythropoietic porphyria (cep) treatment options in Cleveland, OH, this clinical trial (NCT07024316) 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 Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced congenital erythropoietic porphyria (cep) 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 congenital erythropoietic porphyria (cep) clinical trials near you to find additional studies recruiting in your area.

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