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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT01205087
• Collaborator: NasVax Ltd (Industry)
• Enrollment: 36
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis	Drug: OKT3	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Omeprazole

Outcome Measures

Primary Outcome Measures

1. 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. [60 days]

Secondary Outcome Measures

1. This clinical study also will include evaluations for markers of efficacy, as described below. [60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hadassah University Hospital, Liver Unit	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization
• NasVax Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01205087
• Other Study ID Numbers: OKT3-NASH-HMO-CTIL
• First Posted: Sep 20, 2010
• Last Update Posted: Jun 23, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Omeprazole

Study Results

No Results Posted as of Jun 23, 2011