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HMG-CoA Reductase Inhibitor
Pravastatin for Endothelial Injury in Pediatric Patients
Phase 1
Recruiting
Led By Jane Koo, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Summary
This trial is testing if pravastatin, a cholesterol-lowering drug, can protect blood vessel linings in children with high BMI undergoing bone marrow transplants. The goal is to see if it can prevent serious complications by keeping these blood vessels healthy.
Who is the study for?
This trial is for pediatric patients aged 2-25 with an elevated BMI who are scheduled for a stem cell transplant. It's open to all diagnoses, but not for those with kidney issues, taking certain drugs, allergic to pravastatin, unable to take oral medication, or have specific muscle disorders.
What is being tested?
The study tests if Pravastatin can prevent damage to the endothelial lining in blood vessels after bone marrow transplants in young patients with high body weight. The goal is to see if it reduces complications like GVHD and VOD.
What are the potential side effects?
Potential side effects of Pravastatin may include muscle pain or weakness (rhabdomyolysis), liver enzyme changes, and possible allergic reactions. However, this study aims to confirm its safety in the given patient population.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days after bone marrow transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days after bone marrow transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants who adhered to the medication plan
Percentage of participants who developed clinically significant transaminitis, renal dysfunction and rhabdomyolysis
Secondary study objectives
Assessment of SLCO1B1 genotyping
Measurement of sphingosine-1-phosphate (S1P) levels in plasma
Median number of days until neutrophil engraftment
+4 moreSide effects data
From 2013 Phase 4 trial • 252 Patients • NCT013010662%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Enterovesical fistula
1%
Diverticulitis
1%
Atrial septal defect
1%
Transient ischaemic attack
1%
Multiple fractures
1%
Respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Chest pain
1%
Gastroenteritis
1%
Gastroenteritis viral
1%
Herpes dermatitis
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pitavastatin 4 mg QD
Pravastatin 40 mg QD
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pravastatin Prophylactic TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pravastatin
2010
Completed Phase 4
~11530
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
Pravastatin, a commonly used statin, works by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in cholesterol synthesis. This lipid-lowering effect reduces the amount of low-density lipoprotein (LDL) cholesterol in the blood, which is beneficial because high levels of LDL cholesterol can lead to atherosclerosis and further endothelial damage.
Additionally, pravastatin has anti-inflammatory properties that help reduce vascular inflammation, a key factor in endothelial injury. By lowering both cholesterol levels and inflammation, pravastatin helps protect the endothelial lining of blood vessels, reducing the risk of complications such as graft-vs-host disease, thrombotic microangiopathy, and veno-occlusive disease in patients undergoing treatments like bone marrow transplants.
Sustained Focal Vascular Inflammation Accelerates Atherosclerosis in Remote Arteries.Hydroxymethylglutaryl co-enzyme A reductase inhibition attenuates endotoxin-mediated inflammatory responses.
Sustained Focal Vascular Inflammation Accelerates Atherosclerosis in Remote Arteries.Hydroxymethylglutaryl co-enzyme A reductase inhibition attenuates endotoxin-mediated inflammatory responses.
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
831 Previous Clinical Trials
6,564,627 Total Patients Enrolled
Jane Koo, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced.I am currently taking medication that affects liver transport proteins.My condition does not limit my eligibility based on diagnosis.My BMI classifies me as overweight or obese according to CDC guidelines.I am between 2 and 25 years old.I have a condition like muscular dystrophy that increases my risk of muscle breakdown.I am scheduled for a stem cell transplant from a donor.I cannot take medication by mouth or through my intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Pravastatin Prophylactic Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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