Diabetes Mellitus, Insulin-DependentPhase 1/2NCT00008801
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
A Phase 1/2 study testing hOKT3gamma1 (Ala-ala) in people with Diabetes Mellitus, Insulin-Dependent and Diabetes Mellitus, Experimental, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous
- What is being tested?
- hOKT3gamma1 (Ala-ala)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary islet allotransplant
- surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team
- Age 18 or older
- must give written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.
Read the detailed description
Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.
- Conditions
- Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous, Islets of Langerhans Transplantation
- Being tested
- hOKT3gamma1 (Ala-ala)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hOKT3gamma1 (Ala-ala)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Juvenile Diabetes Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008801
- Sponsor's protocol ID
- NCRR-M01RR00400-0672
- Status last verified
- Dec 2003
- First submitted
- 16 Jan 2001
- Last updated
- 1 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
- ClinicalTrials.gov ID
- NCT00008801
- Acronym / sponsor ID
- NCRR-M01RR00400-0672
- Conditions
- Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Experimental, Transplantation, Homologous, Islets of Langerhans Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Juvenile Diabetes Research Foundation
- First posted
- 18 Jan 2001 (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.
The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.
Detailed description
Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary islet allotransplant
- surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team
- Age 18 or older
- must give written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hOKT3gamma1 (Ala-ala) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2005.
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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 1/2 study testing hOKT3gamma1 (Ala-ala) in people with Diabetes Mellitus, Insulin-Dependent and Diabetes Mellitus, Experimental, run by National Center for Research Resources (NCRR) at 1 site in United States.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Nov 2005. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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.
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 1 Nov 2005.