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Histamine H2 Receptor Antagonist

Cimetidine for Protoporphyria

Phase 2
Recruiting
Led By Amy K Dickey, MD
Research Sponsored by Amy K. Dickey, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior enrollment or co-enrollment in the Longitudinal Study of the Porphyrias (PC Study 7201) with a confirmed diagnosis of EPP or XLP
Must not have
Individuals with elevations of porphyrins in plasma or erythrocytes due to other diseases (i.e., secondary porphyrinemia) such as liver and bone marrow diseases
Women who are pregnant, breastfeeding, or actively planning to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after each 3-month treatment period

Summary

This trial tests if cimetidine, a common stomach medicine, can help people with EPP and XLP who suffer from painful light sensitivity. The drug might work by stopping the body from making too much of a substance that causes this sensitivity. Cimetidine is often prescribed for hospitalized patients requiring intravenous nutritional support and has been used to prevent excessive fluid and electrolyte loss in patients with short-bowel syndrome.

Who is the study for?
This trial is for individuals at least 15 years old with a confirmed diagnosis of Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP), who have a history of skin sensitivity to light but are not using other experimental therapies. Participants must be willing to use their smartphone for the study and expose themselves to light weekly.
What is being tested?
The trial is testing if oral Cimetidine can treat protoporphyrias by reducing protoporphyrin levels, improving tolerance to light, and enhancing quality of life. It's compared against a placebo, with outcomes measured through questionnaires and blood tests.
What are the potential side effects?
Cimetidine may cause side effects such as headaches, dizziness, gastrointestinal issues like diarrhea or constipation, tiredness, and in rare cases more serious reactions like heart rhythm problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with EPP or XLP and enrolled in the PC Study 7201.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have high porphyrin levels due to liver or bone marrow disease.
Select...
I am pregnant, breastfeeding, or planning to become pregnant soon.
Select...
I have moderate to severe problems with my kidneys.
Select...
I have had a liver or bone marrow transplant or significant liver issues.
Select...
I don't have a smartphone or won't use it for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after each 3-month treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after each 3-month treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Erythrocyte total protoporphyrin level
Secondary study objectives
Light dose
Patient-reported quality of life
Phototoxic episodes
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CimetidineActive Control1 Intervention
Cimetidine 800mg orally twice daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule orally twice daily

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Erythropoietic Protoporphyria (EPP) is treated by targeting the underlying genetic defects in heme biosynthesis that cause photosensitivity. Cimetidine, a histamine H2 receptor antagonist, is being studied for its potential to reduce protoporphyrin levels, thereby decreasing photosensitivity and improving the quality of life for EPP patients. Cimetidine works by inhibiting the action of histamine on H2 receptors in the stomach, reducing acid production, and potentially influencing heme metabolism. This matters for EPP patients as it offers a non-invasive treatment option that could mitigate the painful cutaneous symptoms associated with light exposure.
[Infantile pyknocytosis: A cause of noenatal hemolytic anemia. Is recombinant erythropoietin an alternative to transfusion?].

Find a Location

Who is running the clinical trial?

University of TexasOTHER
189 Previous Clinical Trials
143,119 Total Patients Enrolled
Amy K. Dickey, M.D.Lead Sponsor
Wake Forest University Health SciencesOTHER
1,357 Previous Clinical Trials
1,031,670 Total Patients Enrolled

Media Library

Cimetidine (Histamine H2 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05020184 — Phase 2
Erythropoietic Protoporphyria Research Study Groups: Placebo, Cimetidine
Erythropoietic Protoporphyria Clinical Trial 2023: Cimetidine Highlights & Side Effects. Trial Name: NCT05020184 — Phase 2
Cimetidine (Histamine H2 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020184 — Phase 2
~2 spots leftby Feb 2025