A Phase IIa Safety study of oral administration of anti-CD3 monoclonal antibody in non-responder genotype-I chronic Hepatitis C subjects, a single-blind, randomized, controlled multi-center study

• Conditions: in non-responder genotype-I chronic Hepatitis C subjects; MedDRA version: 14.0Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001071-40-AT
• Lead Sponsor: InSpira Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-30
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Subjects who have completed the informed consent process culminating with written informed consent by the subject.
•Men and women age 18 to 65 years (inclusive).
•Diagnosis of chronic active HCV infection was based on liver biopsy (within 3 years of initiation of study),
•Patients who failed treatment with Interferon or Peg-Interferon and Ribavirin (<2-log change in HCV level during the 12 weeks of treatment)
•HCV RNA in blood for at Screening Visit, =600 copies/mL
•Abstinence from any alternative medications or vitamin-D-containing supplements for three months prior to initiation of therapy was stipulated.
•Compensated liver disease with the following maximum hematologic, biochemical and serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin = 12 g/dl for women and = 13 g/dl for men, WBC > 3000/mm3, Platelets > 100,000/mm3, Direct bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine - WNL. Child-Pugh score = 6.
•Fasting glucose should be 70 -140 mg/dl, results between 116-140 require HbA1c < 7.5%
•Antinuclear antibodies (ANA) up to +1
•HCV Genotype I patients

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified