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New treatment option for Allogeneic Granulocyte Donation
Official title Improving White Blood Cell Collection From Healthy Donors
ClinicalTrials.gov ID: NCT01553214
What this study is testing
What is Filgrastim?
Filgrastim is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for allogeneic granulocyte donation.
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
- Background: \- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA...
- Age greater than or equal to18 and less than or equal to 75 years
- If hypertension is present, must be well-controlled on medications
- If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications
- If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was...
You likely can't join if
- Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.
- Weight less than 50 kg (110 lbs).
- History of coronary heart disease
- Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100)
- Diabetes mellitus requiring insulin
- Active, symptomatic peptic ulcer disease
See the full eligibility criteria
- Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet...
- Age greater than or equal to18 and less than or equal to 75 years
- If hypertension is present, must be well-controlled on medications
- If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications
- If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The...
- Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.
- Weight less than 50 kg (110 lbs).
- History of coronary heart disease
- Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100)
- Diabetes mellitus requiring insulin
- Active, symptomatic peptic ulcer disease
- History of iritis or episcleritis
- Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required.
- Lithium therapy
- Pregnancy or nursing (breast feeding)
- Renal function eGFR \< 45 ml/min/1.73m(2)
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.