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

Nonalcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205087
• Other study ID #: OKT3-NASH-HMO-CTIL
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2010
• Last updated: June 22, 2011
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-ß (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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Metabolic Syndrome X
• Nonalcoholic Steatohepatitis

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital, Liver Unit	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	NasVax Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	This clinical study also will include evaluations for markers of efficacy, as described below.		60 days	Yes