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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after each 3-month treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after each 3-month treatment period
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 moreTrial 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?].
[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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high porphyrin levels due to liver or bone marrow disease.I am 15 years old or older.You have a known or suspected allergy or intolerance to cimetidine.I am pregnant, breastfeeding, or planning to become pregnant soon.I have moderate to severe problems with my kidneys.I am not taking any drugs or supplements that could affect my safety or the study's goals.I am not willing to expose myself to light until I start feeling initial symptoms.I am diagnosed with EPP or XLP and enrolled in the PC Study 7201.I have had a liver or bone marrow transplant or significant liver issues.I am willing and able to follow the study's procedures and give informed consent.You have a history of skin sensitivity to sunlight that does not cause blisters.I don't have a smartphone or won't use it for the study.I have not taken cimetidine in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cimetidine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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