Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00936403 | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | PHASE2 | COMPLETED | 31 | — | — | Aug 1, 2009 | Jul 1, 2010 | Feb 8, 2017 | 21 | Belgium, Czechia +8 |
| NCT00715689 | Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 | PHASE2 | COMPLETED | 33 | — | — | Jul 1, 2008 | Mar 1, 2009 | Feb 8, 2017 | 3 | Denmark |
| NCT00722540 | Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 | PHASE1 | COMPLETED | 40 | — | — | Jul 1, 2008 | Apr 1, 2009 | Feb 8, 2017 | 1 | Germany |
| NCT01034202 | Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx® | PHASE1 | COMPLETED | 56 | — | — | Aug 1, 2007 | Jan 1, 2008 | Feb 9, 2017 | 1 | Denmark |
| Arm | Type | Description |
|---|---|---|
| NNC126-0083 | EXPERIMENTAL | - |
| Norditropin NordiFlex® | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.02 mg/kg + placebo | PLACEBO_COMPARATOR | - |
| Norditropin® SimpleXx® 0.04 mg/kg + placebo | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NNC126-0083 | DRUG | One single dose administered in four dose levels in an escalating order |
| somatropin | DRUG | A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant |
| placebo | DRUG | Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
| Norditropin® SimpleXx® | DRUG | One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin) |
Inclusion Criteria: * Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml * Pre-pubertal children * Growth hormone replacement treatment for at least three months Exclusion Criteria: * Evidence of tum...