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

NCT ID: NCT01459419

Last Updated: 2011-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-10-31

Brief 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.

Detailed Description

Oral aCD3 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 subjects will be treated at each dosage level, and up to 9 subjects will receive placebo buffered in normal saline that is used as diluents for the MAb. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken orally as part of the study drug cocktail in order to neutralize stomach pH for enhancing stability of the MAb. During the treatment period, subjects will ingest the study drug/s every day for 30 days, and will be followed for clinical and laboratory effects. Subjects will be followed up to Day 60 (30 days after termination of treatment)

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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. Up to 9 subjects will be treated at each dosage level

Group Type: EXPERIMENTAL

anti-CD3 monoclonal antibody

Intervention Type: DRUG

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

Sodium chloride

Up to 9 subjects will receive placebo. Subjects will receive the drug in a similar manner as as the treatment group

Group Type: PLACEBO_COMPARATOR

Sodium Chloride placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Subjects who have undergone surgery within the last 3 months.
• Subjects who have had a prior gastrointestinal surgery.
• Subjects with organ transplants other than cornea or hair transplant.
• Subjects with Inflammatory Bowel Disease, malabsorption, and symptoms of diarrhea.
• Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or malignant disease.
• Subjects who are receiving an elemental diet or parenteral nutrition.
• Subjects who have been treated with any type of immune modulatory drug including systemic steroids or NSAID within the last 4 weeks.
• Subjects who have received either methotrexate or cyclosporine or anti-TNF (infliximab, Remicade) or anti-integrin (namixilab) at any time or who have participated in any other clinical trial within the last 3 months.
• Subjects with a history of coagulopathy.
• ALT level more than 10 times the normal limit.
• Women with childbearing potential unless using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
• Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
• Subjects who are HIV-positive.
• Subjects who are positive for anti-HBcAg
• Subjects with active CMV infection.
• Subjects with autoimmune hepatitis
• Subjects with IgG anti-cardiolipin antibody >16 IU.
• Any prior exposure to anti-CD3 MAb.
• Known sensitivity to any ingredients in the study drug
• Any know autoimmune disease except for the studied disorders
• Subjects with excess alcohol use (> 30 g/day)
• Subjects with drug addiction based on the physician's judgment
• Subjects with TSH >6 mIU/L

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NasVax Ltd

INDUSTRY

Sponsor Role: collaborator

Inspira Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Waldemar Halota, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Univ.Klinik für Innere Medizin IV

Vienna, , Austria

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

Bydgoszcz, Bydgoszcz, Poland

Countries

Austria; Poland

Central Contacts

Waldemar Halota, Prof.

Role: CONTACT

kikchzak@cm.umk.pl

+48 52 325 56

Facility Contacts

Peter Ferenci, Prof.Dr.

Role: primary

peter.ferenci@meduniwien.ac.at

+43 1 40400 4741

Waldemar Halota, Prof

Role: primary

kikchzak@cm.umk.pl

>+48 52 325 5605

Other Identifiers

ISM-10-06

Identifier Type: -

Identifier Source: org_study_id