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Peflutren Lipid Microsphere Injectable

Phase 2

Liver Disease | Small molecule | Gastrointestinal |Lantheus Holdings, Inc.|Trials Updated: Aug 18, 2011

Peflutren Lipid Microsphere Injectable target and mechanism

ModalitySmall molecule

Also known as Peflutren Lipid Microsphere Injectable Suspension

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Peflutren Lipid Microsphere Injectable clinical trials

Peflutren Lipid Microsphere Injectable · 1 trial · 1 indication

Phase 2 1
NCT00162058A Phase II Study of DMP 115 to Assess Focal Liver LesionsLiver Disease
COMPLETED80 Analytics
PHASE2COMPLETED
A Phase II Study of DMP 115 to Assess Focal Liver Lesions
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Study Endpoints

Primary Endpoints

The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.

Secondary Endpoints

The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Interventions

NameTypeDescription
Peflutren Lipid Microsphere Injectable SuspensionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with 1 but \<7 focal liver lesions * Scheduled for liver biopsy within 30 days of study * Scheduled for CT or MR within 30 days of study Exclusion Criteria: * Critically ill subjects * Subjects with right-to-left shunts

Countries:United Kingdom
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Frequently asked questions about Peflutren Lipid Microsphere Injectable

What is Peflutren Lipid Microsphere Injectable?

Peflutren Lipid Microsphere Injectable is an investigational small molecule developed by Lantheus Holdings, Inc. (LNTH) for liver disease. It is formulated as a lipid microsphere injectable suspension and was studied in a Phase 2 trial assessing focal liver lesions. It is not approved and remains in clinical development.

What is Peflutren Lipid Microsphere Injectable used for?

Peflutren Lipid Microsphere Injectable is being developed for liver disease, specifically for the assessment of focal liver lesions. Its only recorded clinical trial enrolled patients with liver disease in the United Kingdom. The drug is investigational and has not been approved for any indication.

Who makes Peflutren Lipid Microsphere Injectable?

Peflutren Lipid Microsphere Injectable is developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. Lantheus is the sponsor of the Phase 2 study of the agent in focal liver lesions.

What phase is Peflutren Lipid Microsphere Injectable in?

Peflutren Lipid Microsphere Injectable is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval.

What clinical trials is Peflutren Lipid Microsphere Injectable in?

Peflutren Lipid Microsphere Injectable has been studied in one completed Phase 2 trial, NCT00162058, titled A Phase II Study of DMP 115 to Assess Focal Liver Lesions. The trial enrolled 80 patients with liver disease in the United Kingdom and was uncontrolled, with no randomization or blinding.

Is Peflutren Lipid Microsphere Injectable the same as Peflutren Lipid Microsphere Injectable Suspension?

Yes. Peflutren Lipid Microsphere Injectable Suspension is an alternative name for Peflutren Lipid Microsphere Injectable. Both refer to the same Lantheus Holdings (LNTH) investigational small molecule being studied in liver disease.