Nonalcoholic SteatohepatitisPhase 2NCT01205087
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
A Phase 2 study testing OKT3 in people with Nonalcoholic Steatohepatitis, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- OKT3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- OKT3
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKT3Drug
Also called Omeprazole
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: OKT3 |
| OKT3 - 0.2 | Active comparator | Not described Receives: Drug: OKT3 |
| OKT3 - 1 | Active comparator | Not described Receives: Drug: OKT3 |
| OKT3 - 5 | Active comparator | Not described Receives: Drug: OKT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (1)
This clinical study also will include evaluations for markers of efficacy, as described below.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- NasVax Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205087
- Sponsor's protocol ID
- OKT3-NASH-HMO-CTIL
- Status last verified
- Jun 2011
- First submitted
- 23 May 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01205087
- Acronym / sponsor ID
- OKT3-NASH-HMO-CTIL
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- NasVax Ltd
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: OKT3 |
| OKT3 - 0.2 | Active comparator | Drug: OKT3 |
| OKT3 - 1 | Active comparator | Drug: OKT3 |
| OKT3 - 5 | Active comparator | Drug: OKT3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKT3Also: OmeprazoleOral 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. | Drug | OKT3 - 0.2, OKT3 - 1, OKT3 - 5, Placebo |
Primary outcome
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
1 secondary outcome
This clinical study also will include evaluations for markers of efficacy, as described below.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OKT3 in people with Nonalcoholic Steatohepatitis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.