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New treatment option for Sickle Cell Disease
Official title Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
ClinicalTrials.gov ID: NCT02447874
What this study is testing
What is Arginine?
Arginine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Also referred to as Arginine Hydrochloride Injection, R-Gene® 10.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 21
You may be able to join if
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- 7-21 years of age
- Weight \>= 25kg (55lbs)
- Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids...
You likely can't join if
- Decision to discharge home from acute care setting.
- Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal)...
- Hemoglobin less than 5 gm/dL
- Immediate Red cell transfusion anticipated
- Renal dysfunction: Creatinine \>1.0 or 2 x baseline
- Mental status or neurological changes
See the full eligibility criteria
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- 7-21 years of age
- Weight \>= 25kg (55lbs)
- Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.
- Decision to discharge home from acute care setting.
- Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO...
- Hemoglobin less than 5 gm/dL
- Immediate Red cell transfusion anticipated
- Renal dysfunction: Creatinine \>1.0 or 2 x baseline
- Mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Pregnancy
- Allergy to arginine
- Previous hospitalization \< 7 days
- Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
- Not an appropriate candidate in the investigator's judgement
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.