Who is sponsoring NCT02200029?

NCT02200029 is sponsored by Abbott.

What condition does NCT02200029 study?

NCT02200029 studies Intrahepatic Cholestasis Associated With Alcoholic Liver Disease.

What drugs are being tested in NCT02200029?

Interventions: Ademetionine IV+tablet, Ademetionine tablet.

What is the status of NCT02200029?

NCT02200029 is currently COMPLETED.

Last reviewed 2015-06-15 · How we verify

Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)

NCT02200029 Phase 3 COMPLETED

A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	75
Start date	2014-06
Completion	2015-02

Conditions

Intrahepatic Cholestasis Associated With Alcoholic Liver Disease

Interventions

Ademetionine IV+tablet
Ademetionine tablet

Primary outcomes

Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT) — from baseline up to the end of treatment visit (56-60 days)
Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline

Countries

Russia