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AST-120

Phase 2

Mild Hepatic Encephalopathy | Small molecule | Gastrointestinal |cbdMD, Inc.|Last Updated: Jun 18, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

Clinical trial landscape

AST-120 · 1 trial · 1 indication

Phase 2 1
NCT00867698AST-120 Used to Treat Mild Hepatic EncephalopathyMild Hepatic Encephalopathy
COMPLETED148 Analytics
PHASE2COMPLETED
AST-120 Used to Treat Mild Hepatic Encephalopathy
Mild Hepatic EncephalopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AST-120 (6g)EXPERIMENTAL2 grams TID
Placebo APLACEBO_COMPARATOR2 grams TID
AST-120 (12g)EXPERIMENTAL4 grams TID
Placebo BPLACEBO_COMPARATOR4 grams TID

Interventions

NameTypeDescription
AST-120DRUGAST-120
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Confirmed cirrhosis of any cause 2. Abnormal RBANS global summary score 3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale 4. MELD score \< or = 25 5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth con...

Countries:United States
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Frequently asked questions about AST-120

What is AST-120 used for?

AST-120 is an investigational small molecule being studied for the treatment of mild hepatic encephalopathy, a condition related to gastrointestinal and liver function. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who is developing AST-120?

AST-120 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The drug is currently in Phase 2 clinical trials for mild hepatic encephalopathy.

What phase is AST-120 in?

AST-120 is in Phase 2 clinical development. It is an investigational drug and has not yet received FDA approval. A Phase 2 clinical trial for mild hepatic encephalopathy has been completed.

What clinical trials is AST-120 in?

AST-120 has been studied in a Phase 2 clinical trial with the identifier NCT00867698. This trial, titled "AST-120 Used to Treat Mild Hepatic Encephalopathy," was completed and enrolled 148 participants in the United States.

Is AST-120 a randomized controlled trial drug?

Yes, AST-120 has been evaluated in a randomized, double-blind, placebo-controlled clinical trial. This Phase 2 study enrolled 148 participants with mild hepatic encephalopathy and was completed in the United States.