Who is sponsoring NCT00608894?

NCT00608894 is sponsored by Veloxis Pharmaceuticals.

What condition does NCT00608894 study?

NCT00608894 studies Autoimmune Hepatitis.

What drugs are being tested in NCT00608894?

Interventions: LCP-Tacro (tacrolimus), Azathioprine.

What is the status of NCT00608894?

NCT00608894 is currently TERMINATED.

Last reviewed 2020-03-06 · How we verify

A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis

NCT00608894 Phase 2 TERMINATED Results posted

An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).

Details

Lead sponsor	Veloxis Pharmaceuticals
Phase	Phase 2
Status	TERMINATED
Enrolment	13
Start date	2007-12
Completion	2009-07

Conditions

Autoimmune Hepatitis

Interventions

LCP-Tacro (tacrolimus)
Azathioprine

Primary outcomes

Biochemical Remission of (AIH) at Month 6. — 6 months
Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.

Countries

United States, Canada