Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

April 30, 2011

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

OKT3

Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.

Trial Locations (1)

Unknown

Hadassah University Hospital, Liver Unit, Jerusalem

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NasVax Ltd

INDUSTRY

lead

Hadassah Medical Organization

OTHER