Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects

PHASE2UnknownINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

October 31, 2013

Conditions
Chronic Hepatitis C
Interventions
DRUG

anti-CD3 monoclonal antibody

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. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken concomitantly orally

DRUG

Sodium Chloride placebo

Sodium chloride will be administered orally every day for 30 days. Up to 9 subjects will be treated at each dosage level. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken concomitantly orally

Trial Locations (2)

A-1090

Univ.Klinik für Innere Medizin IV, Vienna

85 030

Katedra i Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno - Zakaźny im. Tadeusza Browicza, Bydgoszcz

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

NasVax Ltd

INDUSTRY

lead

Inspira Medical AB

INDUSTRY