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Allogeneic Islets of Langerhans

Phase 1

Type 1 Diabetes Mellitus | Monoclonal antibody | Metabolic |Novartis AG|Last Updated: May 8, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00286624Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet TransplantationPHASE1 COMPLETED 6 — — Mar 1, 2003Aug 1, 2006May 8, 20081 United States
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Study Endpoints
Primary Endpoints
• The incidence, timing, and severity of adverse events during one year after the first and any subsequent islet transplants.
1 year
• Incidence and severity of hypoglycemia during the first year after the first and any subsequent islet transplants.
1 yr
• The proportion of recipients who develop alloantibodies directed at islet donor alloantigens during the first year after the first and any subsequent islet transplants.
1 year
Secondary Endpoints
• The proportion of subjects who achieve insulin independence in the first year after single-donor or sequential transplantation.
1 year
• The proportion of islet allograft recipients with full and partial islet graft function at one year after the most recent islet transplant.
1 year
• Glycemic control and insulin secretory responses during the first year after the first and any subsequent transplants.
1 year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAllogeneic islet transplantation with anti-thymocyte globulin induction and cyclosporine and RAD maintenance immunosuppression
Interventions
NameTypeDescription
Allogeneic Islets of LangerhansBIOLOGICALUp to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight.
EverolimusDRUGLoading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter.
anti-thymocyte globulinDRUGA total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2.
CyclosporineDRUGCyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Primary islet allotransplant * Patients with type 1 diabetes mellitus under intensive insulin management * Age 18 or older * Ability to give written informed consent Exclusion Criteria: * Age less than 18 years. * BMI \>26 kg/m2. * Insulin requirement of \> 50 IU per day. * ...

Countries:United States
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