in non-responder genotype-I chronic Hepatitis C subjects MedDRA version: 14.0 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Orthoclone OKT3® (Muromonab)
Product Code: OKT3
Pharmaceutical Form: Oral liquid
INN or Proposed INN: ORTHOCLONE OKT3 (muromonab-CD3)
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
InSpira Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 ( 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety of oral administration of the study drug anti-CD3 MAb in subjects with chronic Hepatitis C.;Secondary Objective: Improvement in one or more of the immune parameters as specified below. Decrease in the concentration of HCV in the blood or in the level of ALT. ;Primary end point(s): Safety assessment will be made by monitoring the subjects for adverse events and by interpreting the results of the various laboratory tests and the subjects’ diaries as outlined in the trial protocol below. ;Timepoint(s) of evaluation of this end point: Day 0, 7, 14, 30 and 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement in one or more of the immune parameters;Timepoint(s) of evaluation of this end point: Day 0, 14, 30 and 60 | — |
Countries
Austria, Poland
Contacts
Public ContactJack Spira
InSpira Medical AB
Outcome results
None listed