Year of PID diagnosis 2004 2003 20. Study 07-42. Trough Serum IgG Concentrations, interim analysis Wash in/wash Efficacy Period out Period Visit 0 3 6 Month 9 12 Month Patient1 6.8 10.4 11.8 10.6 IgG trough concentration (g/L) Patient2 13.3 13.4 12.6 14.2 IgG trough concentration (g/L) The conclusion drawn by CSL regarding efficacy is that the interim analysis of data from two paediatric patients showed that trough serum IgG concentrations were maintained by weekly doses. Paediatric Patients. Combined Studies 05-23 and 07-42 In Study 05-23, a total of 5 children under the age of 12 years were enrolled. A 13 year old paediatric patient from this was considered by the TGA to be eligible for analysis in the paediatric population. An additional two children were enrolled into the 07-42 trial. Results for a total of eight paediatric patients were separately summarised in the sponsor’s current Australian submission. These patients comprised the Paediatric population for the Efficacy Period. Six (75%) patients were male and two (25%) were female and all were White (100%). The mean age was 9.85 (median 10.20, range: 5.9 to13.4) years and the mean weight was 35.25 (median 34.40, range: 20.2 to 64.5) kg. Demographic and baseline data are summarised in Table 21 below. Table 21. Combined paediatric demographics and baseline information, paediatric population. Baseline Characteristics Paediatric population N=8 Age (years) n 8 Mean (SD) 9.85 (2.22) Median 10.20 Min, Max 5.9, 13.4 Sex, n (%) Male 6 (75.0%) Female 2 (25.0%) Race, n (%) White 8 (100.0%) Screening weight (kg) 8 n 35.25 (13.98)
Year of PID diagnosis 2004 2003 20. Study 07-42. Trough Serum IgG Concentrations, interim analysis Wash in/wash out Period Efficacy Period Visit 0 3 6 Month 9 12 Month Patient1 IgG trough concentration (g/L) 6.8 10.4 11.8 10.6 Patient2 IgG trough concentration (g/L) 13.3 13.4 12.6 14.2 The conclusion drawn by CSL regarding efficacy is that the interim analysis of data from two paediatric patients showed that trough serum IgG concentrations were maintained by weekly doses. Paediatric Patients. Combined Studies 05-23 and 07-42 In Study 05-23, a total of 5 children under the age of 12 years were enrolled. A 13 year old paediatric patient from this was considered by the TGA to be eligible for analysis in the paediatric population. An additional two children were enrolled into the 07-42 trial. Results for a total of eight paediatric patients were separately summarised in the sponsor’s current Australian submission. These patients comprised the Paediatric population for the Efficacy Period. Six (75%) patients were male and two (25%) were female and all were White (100%). The mean age was 9.85 (median 10.20, range: 5.9 to13.4) years and the mean weight was 35.25 (median 34.40, range: 20.2 to 64.5) kg. Demographic and baseline data are summarised in Table 21 below. Table 21. Combined paediatric demographics and baseline information, paediatric population. Baseline Characteristics Paediatric population N=8 Age (years) n Mean (SD) Median Min, Max 8 9.85 (2.22) 10.20 5.9, 13.4 Sex, n (%) Male Female 6 (75.0%) 2 (25.0%) Race, n (%) White 8 (100.0%) Screening weight (kg) n 8 35.25 (13.98)
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