Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
Brief Summary: Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.


Options:
A: Arm Label: Insulin glargine + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: omega-3 polyunsaturated fatty acids (PUFA), Device: reusable pen device for insulin injection | Arm Label: Insulin glargine + placebo; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: placebo, Device: reusable pen device for insulin injection | Arm Label: Standard care + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: omega-3 polyunsaturated fatty acids (PUFA) | Arm Label: Standard care + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: insulin glargine (HOE901); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo | Intervention Type: DRUG; Name: omega-3 polyunsaturated fatty acids (PUFA); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Standard care + omega-3 polyunsaturated fatty acids | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Insulin glargine + placebo, Standard care + placebo | Intervention Type: DEVICE; Name: reusable pen device for insulin injection; Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo
B: Arm Label: prGCD 30 Units/kg; Type: EXPERIMENTAL; Interventions: Drug: Plant cell expressed recombinant glucocerebrosidase (prGCD) | Arm Label: prGCD 60 Units/kg; Type: EXPERIMENTAL; Interventions: Drug: Plant cell expressed recombinant glucocerebrosidase (prGCD) | Intervention Type: DRUG; Name: Plant cell expressed recombinant glucocerebrosidase (prGCD); Assigned to Arm(s): prGCD 30 Units/kg | Intervention Type: DRUG; Name: Plant cell expressed recombinant glucocerebrosidase (prGCD); Assigned to Arm(s): prGCD 60 Units/kg
C: Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: Eliglustat tartrate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Eliglustat tartrate; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Eliglustat tartrate; Type: EXPERIMENTAL; Interventions: Drug: Eliglustat tartrate | Intervention Type: DRUG; Name: Eliglustat tartrate; Assigned to Arm(s): Eliglustat tartrate

Answer: B