MedTrace Logo

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

NCT01459419 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-10-25

No results posted yet for this study

Summary

The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is justified on the basis of scientific and medical reasons. There are data in multiple animal models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and induces regulatory T cells and immune-modulation as desired in clinical studies. These observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone induced the desired immune-modulation in terms of immunological markers for regulatory T cells and appropriate rises and declines in certain cytokine levels.

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

Sponsors & Collaborators

  • NasVax Ltd

    collaborator INDUSTRY

  • Inspira Medical AB

    lead INDUSTRY

Principal Investigators

  • Waldemar Halota, Prof · Katedra i Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno - Zakaźny im. Tadeusza Browicza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-10-31

Countries

  • Austria
  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459419 on ClinicalTrials.gov