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Dextrose, 5% in Water

Phase 3

Immunologic Deficiency Syndrome | Small molecule | Rare Disease |Grifols, S.A.|Last Updated: Sep 25, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Dextrose, 5% in Water · 1 trial · 5 indications

Phase 3 1
NCT00220766Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency PatientsImmunologic Deficiency Syndrome
COMPLETED100 Analytics
PHASE3COMPLETED
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Immunologic Deficiency SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Infusion related adverse events
within 72 hours after infusion

Secondary Endpoints

All adverse events
within 72 hours after infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALInfusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Group 2EXPERIMENTALInfusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)

Interventions

NameTypeDescription
Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography PurifiedDRUG -
Dextrose, 5% in WaterDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial * Signed an informed consent written informed consent prior to initiation of any study related procedures * Receiving reg...

Countries:United StatesCanada
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Frequently asked questions about Dextrose, 5% in Water

What is Dextrose, 5% in Water used for?

Dextrose, 5% in Water is used in the treatment of Immunologic Deficiency Syndrome, a rare disease. It is a small molecule being developed by Grifols, S.A. The drug is currently in Phase 3 clinical development for this indication.

Who makes Dextrose, 5% in Water?

Dextrose, 5% in Water is being developed by Grifols, S.A., a company listed on the stock exchange under the ticker GRFS. The drug is in Phase 3 clinical development for Immunologic Deficiency Syndrome.

What phase is Dextrose, 5% in Water in?

Dextrose, 5% in Water is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of Immunologic Deficiency Syndrome, a rare disease. The drug has not been approved and remains in clinical trials.

What clinical trials is Dextrose, 5% in Water in?

Dextrose, 5% in Water is associated with clinical trial NCT00220766, titled "Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients." This Phase 3 trial has been completed and enrolled 100 participants in the United States and Canada.

What conditions does Dextrose, 5% in Water target in clinical trials?

In clinical trial NCT00220766, Dextrose, 5% in Water is studied in patients with Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, and Common Variable Immunodeficiency. The trial enrolled adults aged 18 years and older.