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Generated: February 23, 2019

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CLINICAL TRIALS PROFILE FOR BUPHENYL

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Clinical Trials for Buphenyl

Trial ID Title Status Sponsor Phase Summary
NCT00345605 Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle disorder that is characterized specifically by high levels of argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for serious liver damage, which may be due to the elevated levels of argininosuccinic acid. Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased arginine dose (in addition to a normal regimen of protein) will improve short-term liver function and decrease plasma citrulline and ASA levels in people with ASA.
NCT00345605 Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder Completed Office of Rare Diseases (ORD) Phase 2 Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle disorder that is characterized specifically by high levels of argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for serious liver damage, which may be due to the elevated levels of argininosuccinic acid. Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased arginine dose (in addition to a normal regimen of protein) will improve short-term liver function and decrease plasma citrulline and ASA levels in people with ASA.
NCT00345605 Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder Completed Rare Diseases Clinical Research Network Phase 2 Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle disorder that is characterized specifically by high levels of argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for serious liver damage, which may be due to the elevated levels of argininosuccinic acid. Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased arginine dose (in addition to a normal regimen of protein) will improve short-term liver function and decrease plasma citrulline and ASA levels in people with ASA.
NCT00345605 Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder Completed Brendan Lee Phase 2 Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle disorder that is characterized specifically by high levels of argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for serious liver damage, which may be due to the elevated levels of argininosuccinic acid. Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased arginine dose (in addition to a normal regimen of protein) will improve short-term liver function and decrease plasma citrulline and ASA levels in people with ASA.
NCT00533559 Mechanism of Fatty Acid-induced Impairment of Glucose-simulated Insulin Secretion - Effect of Buphenyl Completed University Health Network, Toronto Phase 4 An increase of plasma free fatty acids impairs insulin secretion and insulin sensitivity, thereby playing an important role in causing type 2 diabetes. Lipotoxicity plays an important role in the progression from normal glucose tolerance to fasting hyperglycemia and coversion to frank type 2 diabetes. A recent publication in the journal Science showed that buphenyl, when given to obese diabetic mice, resulted in normalization of hyperglycemia, restoration of systemic insulin sensitivity, resolution of fatty liver disease and inhancement of insulin action in liver, muscle and adipose tissue. the mechanism of action is believed to be due to reduction of endoplasmic reticulum (ER) stress. Buphenyl is currently approved for the treatment of rare inherited disorders of the urea cycle. We plan to administer Buphenyl orally to humans at a dose far lower than that used for the treatment of urea cycle disorders for 2 weeks prior to the testing of pancreatic function. One potential mechanism whereby chromically elevated plasma FFAs and glucose impairment beta cell function and insuln sensitivity is by ER stress and this can be prevented by administeration of buphenyl.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Buphenyl

Condition Name

Condition Name for Buphenyl
Intervention Trials
Byler Disease 2
Urea Cycle Disorders 2
Amino Acid Metabolism, Inborn Errors 1
Insulin Resistance 1
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Condition MeSH

Condition MeSH for Buphenyl
Intervention Trials
Cholestasis, Intrahepatic 2
Urea Cycle Disorders, Inborn 2
Fibrosis 1
Metabolism, Inborn Errors 1
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Clinical Trial Locations for Buphenyl

Trials by Country

Trials by Country for Buphenyl
Location Trials
United States 7
Canada 1
Ukraine 1
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Trials by US State

Trials by US State for Buphenyl
Location Trials
Texas 3
Pennsylvania 1
Maryland 1
Alabama 1
Minnesota 1
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Clinical Trial Progress for Buphenyl

Clinical Trial Phase

Clinical Trial Phase for Buphenyl
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Buphenyl
Clinical Trial Phase Trials
Completed 4
No longer available 2
Not yet recruiting 1
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Clinical Trial Sponsors for Buphenyl

Sponsor Name

Sponsor Name for Buphenyl
Sponsor Trials
University of Pittsburgh 2
Horizon Pharma Ireland, Ltd., Dublin Ireland 2
Brendan Lee 2
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Sponsor Type

Sponsor Type for Buphenyl
Sponsor Trials
Other 10
NIH 2
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Chubb
Deloitte
Farmers Insurance
Boehringer Ingelheim
Baxter
Cantor Fitzgerald
Daiichi Sankyo
Healthtrust

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