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Peflutren Lipid Microsphere Injectable

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

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
Liver DiseaseUnlock trial analytics

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 used for?

Peflutren Lipid Microsphere Injectable is an investigational drug being studied for use in liver disease, specifically to assess focal liver lesions. It is currently in Phase 2 clinical development and is not approved by the FDA.

Who makes Peflutren Lipid Microsphere Injectable?

Peflutren Lipid Microsphere Injectable is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH.

What phase is Peflutren Lipid Microsphere Injectable in?

Peflutren Lipid Microsphere Injectable is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA.

What clinical trials is Peflutren Lipid Microsphere Injectable in?

Peflutren Lipid Microsphere Injectable has one completed Phase 2 clinical trial, identified as NCT00162058, titled "A Phase II Study of DMP 115 to Assess Focal Liver Lesions." The trial enrolled 80 participants in the United Kingdom.

Is Peflutren Lipid Microsphere Injectable the same as DMP 115?

Yes, Peflutren Lipid Microsphere Injectable is also known as DMP 115. The Phase 2 clinical trial NCT00162058 refers to the drug as DMP 115 in its title.