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Benserazide for Beta Thalassemia (PB04-001 Trial)
PB04-001 Trial Summary
This trial is testing a drug that could improve the lives of people with beta thalassemia or other hemoglobinopathies by increasing the levels of fetal globin protein.
PB04-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPB04-001 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PB04-001 Trial Design
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Who is running the clinical trial?
Media Library
- I haven't used any drugs to increase red blood cells in the last 90 days.I have not had a fever over 38.5°C in the last week.I am currently taking medication for depression or Parkinson's disease.You currently have a problem with using drugs or alcohol.I am 18 years old or older.I need oxygen therapy for my high blood pressure in the lungs.My average hemoglobin levels have been between 6.0 and 10.0 g/dL in the last 6 months.I am not pregnant and agree to use birth control during the study.I have an untreated HIV or hepatitis C infection.I have been diagnosed with narrow angle glaucoma.I have received a blood transfusion in the last 2 months.I am part of a program that requires regular blood transfusions.You have other health conditions that could greatly increase your risk for participating in the study, as determined by the doctor in charge.I have a type of thalassemia that doesn't always require blood transfusions.I have had a fracture due to weak bones.
- Group 1: Low dose
- Group 2: Middle dose
- Group 3: High dose 3 days per week
- Group 4: High dose 5 days per week
- Group 5: Sickle Cell Disease Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What outcomes is this research endeavor hoping to accomplish?
"Over a 4 week period, the main goal of this research is to assess Safety and Tolerability. Secondary endpoints being measured are F-cells (percentage of red blood cells containing HbF), Soluble transferrin receptors (ng/ml) and HbF protein per cell (Mean fluorescent intensity [MFI])."
How many participants are involved in this trial at present?
"For its successful completion, the trial necessitates 36 qualified patients. Those interested can register at clinics like Weil Cornell Medicine in New york City and University Health Network/Toronto General Hospital of Toronto, Canada."
Are there any vacancies for participation in this experiment?
"As per clinicaltrials.gov, this medical experiment is currently in the process of recruiting volunteers and has been since October 5th 2020. The trial's details were last updated on April 9th 2022."
What are the geographical points of reference for this trial?
"Presently, the trial is taking place at 5 different sites situated in New york, Toronto and Oakland as well as other cities. To reduce travel costs associated with enrollment, it may be wise to select a clinic located near you."
Is Benserazide Only Product being tested in any other clinical trials?
"Currently, a single medical trial is currently underway to study the efficacy of Benserazide Only Product. This Phase 3 clinical trial is based in Boston, Massachusetts and there are 5 other locations that have been recruited for this research."
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