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Arginine Therapy for Sickle Cell Disease (STArT Trial)
STArT Trial Summary
This trial is testing whether IV arginine therapy is effective and safe for children with VOE in SCD.
STArT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTArT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STArT Trial Design
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Who is running the clinical trial?
Media Library
- I am 18 or older but cannot make medical decisions for myself.I have not taken glutamine in the last 30 days.You are allergic to arginine.It's been over 12 hours since my last IV pain medication in the hospital.I have had a recent stroke or there are concerns I might have one.I have been diagnosed with sickle cell disease.I started a new sickle cell disease medication less than 3 months ago.I have used ketamine in the ER for a pain crisis.My hemoglobin is below 5 gm/dL or I urgently need a blood transfusion.I have recent changes in my mental state or neurological condition.I do not speak English or Spanish.I respond well to IV pain medication.I visited the ER 3+ times for sickle cell pain and received opioids in the last week.I have low blood pressure needing treatment or have been unstable or in septic shock.I have used inhaled nitric oxide, sildenafil, or arginine in the last month.I have had severe pain from sickle cell disease treated with strong painkillers.I am between 3 and 21 years old.
- Group 1: Arginine Hydrochloride
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this study widely available to patients in America?
"This trial is currently taking place at 10 locations, which include Nationwide Children's Hospital in Columbus, Medical College of Wisconsin/Wisconsin Children's Hospital in Wauwatosa, and Children's Hospital Los Angeles in Los Angeles."
What medical conditions is Arginine Hydrochloride commonly used to treat?
"Arginine Hydrochloride is a medical treatment that is often used to manage pituitary dwarfism. This drug can also be used to ameliorate conditions like pituitary stimulant, amino acid supplementation, and enzymes."
What does the FDA think about Arginine Hydrochloride?
"Arginine Hydrochloride is estimated to be a safe drug, with a score of 3. This is because it is a Phase 3 trial, meaning that there is both some evidence of efficacy as well as multiple rounds of supportive safety data."
Are there any available positions for patients who wish to participate in this research?
"The listed clinical trial on clinicaltrials.gov is currently looking for willing participants. The study was first posted on June 21st, 2021 and was last updated on January 12th, 2022."
Are individuals above the age of 45 able to participate in this research project?
"According to the eligibility requirements listed on the website, patients must be aged 3 to 21 in order to participate in this trial. Out of the 230 total trials, 137 are for patients that are under 18 and 93 are for patients over the age of 65."
For whom is this trial designed?
"Anemic and sickle cell patients between the ages of 3 and 21 are encouraged to sign up for this clinical trial. A little over 300 patients are needed for the study."
Are there other ongoing tests that are using Arginine Hydrochloride?
"Arginine Hydrochloride was first researched in 2007 at Surgical Intensive Care Unit Regional Hospital Jessa. Since that time, there have been 297 completed studies. Currently, 14 clinical trials are still recruiting patients, with a large number of these studies based in Columbus, Ohio."
Have similar investigations been conducted in the past?
"Arginine Hydrochloride has been under scientific investigation since 2007. The initial study was completed in that year and funded by Baxter Healthcare Corporation. This trial, which had 4640 participants, led to Arginine Hydrochloride's Phase 4 drug approval. As of now, there are 14 clinical trials underway for Arginine Hydrochloride in 24 cities and 11 countries."
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