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The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif.
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Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month.
Cohort C comprised eight women taking oral estrogen contraceptives. The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
However, they occurred in 5% or less of the patient group. The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years.
They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function.Contact us if you experience any difficulty logging in.– An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain.Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose.These findings were almost superimposable with those in the ANSWER registry. At baseline, the mean hemoglobin A was 5.2%; this was unchanged at 3 years. The most commonly reported adverse event was injection site pain (48%).Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data. Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly.During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.This put the group above the maximum response target of 1.5 SDs.The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level.