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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02952885 | Strict IGF-1 Control in Acromegaly | PHASE3 | COMPLETED | 10 | — | — | Jul 27, 2017 | May 7, 2020 | Nov 22, 2021 | 5 | Canada |
| Arm | Type | Description |
|---|---|---|
| Pegvisomant | EXPERIMENTAL | Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting. |
| Name | Type | Description |
|---|---|---|
| Pegvisomant | DRUG | Study medications will be prescribed as per clinical practice with PEGV being added, or optimally dosed, at the Month 0 visit. Subjects who are naïve to PEGV should start their injections from 10 mg twice a week to 10 mg daily if used as combination therapy or 10 to 20 mg daily if used as monotherapy. Maximum dosing should not exceed 40mg/day. Dosing of PEGV can be adjusted as per clinical judgement to meet the normalization of IGF-1 levels (\<1.0 ULN) in increments of 5-10mg/day. In the event of a reduction in IGF-1 below the LLN, the dose of PEGV could be decreased by 5-10 mg/day. |
Inclusion Criteria: * Adult patients (at least 18 years old) with confirmed acromegaly whose IGF-I levels are persistently but modestly (1.0 ULN \< \[IGF-1 serum level\] \< 1.5 ULN) elevated following medical therapy such as SSA, PEGV, cabergoline alone or in combination. Exclusion Criteria: 1. P...