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Pentoxifylline

Phase 2

Primary Biliary Cirrhosis | Small molecule | Gastrointestinal |Community Health Systems, Inc.|Last Updated: Dec 9, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Pentoxifylline · 1 trial · 1 indication

Phase 2 1
NCT01249092Pentoxifylline for Primary Biliary CirrhosisPrimary Biliary Cirrhosis
COMPLETED20 Analytics
PHASE2COMPLETED
Pentoxifylline for Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
NCT0124909220
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Study Endpoints

Primary Endpoints

Change in Serum Alkaline Phosphatase Levels.
6 months

Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared.

Secondary Endpoints

Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.
6 months
Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pentoxifylline 400 mg TIDEXPERIMENTALThis study is an open label pilot with only one arm.

Interventions

NameTypeDescription
PentoxifyllineDRUGPatients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.
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Eligibility Criteria

Age Range18 Years to 76 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients ages 18 to 76 years. * Established diagnosis of PBC based on at least three of the following criteria: * Detectable anti-mitochondrial antibodies (AMA) * Cholestatic biochemical pattern * Liver biopsy compatible with PBC * Appropriate exclusio...

Countries:United States
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