Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
NasVax Ltd
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01205087
First received: May 23, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.


Condition Intervention Phase
Nonalcoholic Steatohepatitis
Drug: OKT3
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody in Patients With the Metabolic Syndrome PHASE IIa A Single-blinded Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome. [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • This clinical study also will include evaluations for markers of efficacy, as described below. [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: OKT3
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 of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other Name: Omeprazole
Active Comparator: OKT3 - 0.2 Drug: OKT3
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 of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other Name: Omeprazole
Active Comparator: OKT3 - 1 Drug: OKT3
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 of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other Name: Omeprazole
Active Comparator: OKT3 - 5 Drug: OKT3
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 of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other Name: Omeprazole

Detailed Description:

PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have completed the informed consent process culminating with written informed consent by the subject.
  2. Men and women age 18 to 75 years (inclusive)
  3. Patients with biopsy proven NASH within the last 3 years
  4. Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance.
  5. HBA1C between 5.5 and 14%.

Exclusion Criteria:

  1. Subjects who have undergone surgery within the last 3 months.
  2. Subjects who have had a prior gastrointestinal surgery.
  3. Subjects with a clinically significant infectious, immune mediated or malignant disease
  4. Subjects who are receiving an elemental diet or parenteral nutrition.
  5. Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks
  6. Subjects who have received either methotrexate or cyclosporine or anti TNF-β (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
  7. Subjects with a history of coagulopathy.
  8. Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
  9. Subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
  10. Subjects who are HIV-positive.
  11. Subjects who are HBV-positive
  12. Subjects who are HCV-positive.
  13. Subjects with active CMV
  14. Subjects with anemia (Hb <10.5 gm/dl).
  15. Subjects with thrombocytopenia (platelets <100K/µl).
  16. Subjects with lymphopenia (absolute lymphocyte count <0.7).
  17. Subjects with IgG anti-cardiolipin antibody >16 IU.
  18. Prior exposure to anti-CD3 MAb.
  19. Known sensitivity to any ingredients in the study drug
  20. Any know autoimmune disease except for the studied disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205087

Locations
Israel
Hadassah University Hospital, Liver Unit
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
NasVax Ltd
  More Information

No publications provided

Responsible Party: Gadi Lalazar, M.D., Department of Medicine, Hadassah University Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01205087     History of Changes
Other Study ID Numbers: OKT3-NASH-HMO-CTIL
Study First Received: May 23, 2010
Last Updated: June 22, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014