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

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
OKT3
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah University Hospital, Liver Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

OKT3 - 0.2

OKT3 - 1

OKT3 - 5

Arm Description

Outcomes

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.

Secondary Outcome Measures

This clinical study also will include evaluations for markers of efficacy, as described below.

Full Information

First Posted
May 23, 2010
Last Updated
June 22, 2011
Sponsor
Hadassah Medical Organization
Collaborators
NasVax Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01205087
Brief Title
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
NasVax Ltd

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
OKT3 - 0.2
Arm Type
Active Comparator
Arm Title
OKT3 - 1
Arm Type
Active Comparator
Arm Title
OKT3 - 5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
OKT3
Other Intervention Name(s)
Omeprazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
This clinical study also will include evaluations for markers of efficacy, as described below.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 75 years (inclusive) Patients with biopsy proven NASH within the last 3 years 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. HBA1C between 5.5 and 14%. Exclusion Criteria: Subjects who have undergone surgery within the last 3 months. Subjects who have had a prior gastrointestinal surgery. Subjects with a clinically significant 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 steroids or NSAID within the last 4 weeks 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. Subjects with a history of coagulopathy. 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. 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. Subjects who are HIV-positive. Subjects who are HBV-positive Subjects who are HCV-positive. Subjects with active CMV Subjects with anemia (Hb <10.5 gm/dl). Subjects with thrombocytopenia (platelets <100K/µl). Subjects with lymphopenia (absolute lymphocyte count <0.7). Subjects with IgG anti-cardiolipin antibody >16 IU. Prior exposure to anti-CD3 MAb. Known sensitivity to any ingredients in the study drug Any know autoimmune disease except for the studied disorders.
Facility Information:
Facility Name
Hadassah University Hospital, Liver Unit
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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