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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 100 days after bone marrow transplant
Awards & highlights
Study Summary
This trial is testing whether the drug pravastatin is safe and effective in reducing endothelial injury in patients undergoing bone marrow transplant.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who adhered to the medication plan
Percentage of participants who developed clinically significant transaminitis, renal dysfunction and rhabdomyolysis
Secondary outcome measures
Assessment of SLCO1B1 genotyping
Measurement of sphingosine-1-phosphate (S1P) levels in plasma
Median number of days until neutrophil engraftment
+5 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%
Atrial septal defect
1%
Diverticulitis
1%
Enterovesical fistula
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
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,571 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left in this research project?
"According to clinicaltrials.gov, this research project is presently recruiting patients. It was posted on the 1st of November 2022 and revised 11th October 2022."
Answered by AI
Is Pravastatin a reliable pharmaceutical for protecting one's health?
"Given the limited clinical data available and that this is a Phase 1 trial, our team at Power assigned Pravastatin a safety score of 1."
Answered by AI
To what extent has this research enrolled participants?
"That is correct. According to the information available on clinicaltrials.gov, this research was initially posted on November 1st 2022 and has since been updated as of October 11th 2022. This study will be employing 20 participants from a single medical centre."
Answered by AI
Are my characteristics compatible with the requirements of this clinical trial?
"This trial is accepting approximately 20 applicants who have hematopoietic stem cells and are aged between 2 to 25."
Answered by AI
Can individuals above the age of forty participate in this trial?
"The minimum age for participation in this medical trial is 2, and the upper limit of 25. If you do not meet these requirements there are still 298 trials available to people under 18 or 624 studies open to those over 65 years old."
Answered by AI
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