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Extensively Hydrolyzed formula

Phase 3

Cow Milk Allergy | Unknown | Other |United Therapeutics Corporation|Last Updated: May 15, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Extensively Hydrolyzed formula · 2 trials · 1 indication

Phase 3 2
NCT02711163Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed FormulaCow Milk Allergy
COMPLETED30 Analytics
NCT02351531Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk AllergyCow Milk Allergy
COMPLETED32 Analytics
PHASE3COMPLETED
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Cow Milk Allergy
NCT0271116330
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PHASE3COMPLETED
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Cow Milk Allergy
NCT0235153132
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Study Endpoints

Primary Endpoints

Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
7 days
Number of patients dropped out for intolerance
2 weeks

Secondary Endpoints

Regurgitation assessed through Vandenplas score
7, 45 and 90 days
Vomiting (weekly frequency)
7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)
7, 45 and 90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Extensively hydrolyzed formulaEXPERIMENTALFeeding extensively hydrolyzed formula
Amino acid formulaPLACEBO_COMPARATORFeeding amino acid formula
New Thickened Extensively Hydrolyzed formulaEXPERIMENTAL -

Interventions

NameTypeDescription
Extensively Hydrolyzed formulaDIETARY_SUPPLEMENT -
Amino acid formulaDIETARY_SUPPLEMENT -
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Eligibility Criteria

Age Range1 Month to 36 Months
SexALL
Healthy VolunteersNo
Study Sites1

Main Inclusion Criteria: Infants: * with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months, * successfully fed an eviction diet for at least 2 weeks Main Non-inclusion Criteria: Infants: * fed with an extensively hydrolyzed formula with no improvement ...

Countries:ItalyBelgiumFrance
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Frequently asked questions about Extensively Hydrolyzed formula

What is Extensively Hydrolyzed formula used for?

Extensively Hydrolyzed formula is an investigational formula being studied for the management of cow milk allergy in infants. It is currently in Phase 3 clinical development, with two completed trials evaluating its efficacy and hypoallergenicity in this patient population.

Who makes Extensively Hydrolyzed formula?

Extensively Hydrolyzed formula is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting Phase 3 clinical trials to evaluate the formula's use in infants with cow milk allergy.

What phase is Extensively Hydrolyzed formula in?

Extensively Hydrolyzed formula is in Phase 3 clinical development. Two Phase 3 trials have been completed, both focusing on cow milk allergy in infants. The formula is investigational and has not been approved by regulatory authorities.

What clinical trials is Extensively Hydrolyzed formula in?

Extensively Hydrolyzed formula has been studied in two completed Phase 3 trials: NCT02351531, which evaluated its efficacy in infants with confirmed cow milk allergy across Belgium, France, and Italy, and NCT02711163, which assessed its hypoallergenicity in Italy. Both trials enrolled infants aged 1 month and older.

Is Extensively Hydrolyzed formula the same as a standard cow milk formula?

Extensively Hydrolyzed formula is a specialized formula designed for infants with cow milk allergy. It is not a standard cow milk formula, as it is being developed specifically to address allergic reactions in this population. Its hypoallergenic properties are being evaluated in clinical trials.