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A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study To Evaluate The Efficacy And Safety Of Elafibranor 80 Mg On Long-Term Clinical Outcomes In Adult Participants With Primary Biliary Cholangitis (PBC)
Rochester, Minn.
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).
PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.
The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.
This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.
The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).
This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
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AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Effect Of Seladelpar On Clinical Outcomes In Patients With Primary Biliary Cholangitis (PBC) And Compensated Cirrhosis
Rochester, Minn.
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Closed for Enrollment
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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study To Evaluate The Efficacy And Safety Of Saroglitazar Magnesium In Subjects With Primary Biliary Cholangitis
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to to evaluate the effectiveness and safety of Saroglitazar Magnesium’s optimal dose (1 or 2 mg) and placebo in subjects with primary biliary cholangitis (PBC).
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety, Tolerability, And Efficacy Of GS-9674 In Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis
Rochester, Minn.
The primary purpose of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
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A Prospective, Randomized, Multi-centered, Placebo-controlled, Clinical Trial Of Oral Vancomycin In Adults With Primary Sclerosing Cholangitis
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to to assess the effects of different Oral Vancomycin (OV) doses on the clinical and biochemical course in adult patients with Primary Sclerosing Cholangitis (PSC).
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A Randomized Double-Blind Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Volixibat In The Treatment Of Cholestatic Pruritus In Patients With Primary Sclerosing Cholangitis
Rochester, Minn.
The purpose of this study is to learn more about volixibat for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
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A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Volixibat In The Treatment Of Cholestatic Pruritus In Patients With Primary Biliary Cholangitis (VANTAGE)
Rochester, Minn.
The purpose of this study is investigating the safety and effectiveness of Volixibat in the treatment of cholestatic pruritis.
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Investigation Of The Activity Of Vidofludimus Calcium, A Novel, Orally Available, Small Molecule Inhibitor Of Dihydroorotate Dehydrogenase, As A Treatment For Primary Sclerosing Cholangitis (PSC)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period on the clinical course and progression of primary sclerosing cholangitis.
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