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

NCT01459419 | Unknown Phase 2

• 1 other identifier: ISM-10-06
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• This clinical study is designed to evaluate as Primary Objective the safety of oral administration of the study drug anti-CD3 MAb to non responder genotype I subjects with the chronic Hepatitis C.

  The safety and tolerability of oral administration of the study drug cocktail will be evaluated at Days 7, 14, 21 and 30 by physical examinations and thorough medical history and laboratory evaluations as described below and by the subject through his/her diary entries. In addition, subjects will be assessed for safety at Day 60

  60

Secondary Outcomes (2)

• Decrease in the concentration of HCV

  30 days

• Liver function test

  30 days

Study Arms (2)

anti-CD3 monoclonal antibody

EXPERIMENTAL

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

Drug: anti-CD3 monoclonal antibody

Sodium chloride

PLACEBO COMPARATOR

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

Drug: Sodium Chloride placebo

Interventions

anti-CD3 monoclonal antibody 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

anti-CD3 monoclonal antibody

Sodium Chloride placebo 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

Sodium chloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inspira Medical AB: lead
• NasVax Ltd: collaborator

Study Sites (2)

Univ.Klinik für Innere Medizin IV

Vienna, A-1090, Austria

Location

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

Bydgoszcz, Bydgoszcz, 85 030, Poland

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Waldemar Halota, Prof

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waldemar Halota, Prof.

CONTACT

+48 52 325 56; kikchzak@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2011
• First Posted: October 25, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

AU (1); PL (1)