Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema
Brief Summary: The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.


Options:
A: Arm Label: Higher-volume placebo, then low-volume C1-esterase inhibitor; Type: EXPERIMENTAL; Interventions: Biological: Low-volume C1-esterase inhibitor, Biological: Higher-volume placebo | Arm Label: Low-volume C1-esterase inhibitor, then higher-volume placebo; Type: EXPERIMENTAL; Interventions: Biological: Low-volume C1-esterase inhibitor, Biological: Higher-volume placebo | Arm Label: Low-volume placebo, then higher-volume C1-esterase inhibitor; Type: EXPERIMENTAL; Interventions: Biological: Higher-volume C1-esterase inhibitor, Biological: Low-volume placebo | Arm Label: Higher-volume C1-esterase inhibitor, then low-volume placebo; Type: EXPERIMENTAL; Interventions: Biological: Higher-volume C1-esterase inhibitor, Biological: Low-volume placebo | Intervention Type: BIOLOGICAL; Name: Low-volume C1-esterase inhibitor; Assigned to Arm(s): Higher-volume placebo, then low-volume C1-esterase inhibitor, Low-volume C1-esterase inhibitor, then higher-volume placebo | Intervention Type: BIOLOGICAL; Name: Higher-volume C1-esterase inhibitor; Assigned to Arm(s): Higher-volume C1-esterase inhibitor, then low-volume placebo, Low-volume placebo, then higher-volume C1-esterase inhibitor | Intervention Type: BIOLOGICAL; Name: Low-volume placebo; Assigned to Arm(s): Higher-volume C1-esterase inhibitor, then low-volume placebo, Low-volume placebo, then higher-volume C1-esterase inhibitor | Intervention Type: BIOLOGICAL; Name: Higher-volume placebo; Assigned to Arm(s): Higher-volume placebo, then low-volume C1-esterase inhibitor, Low-volume C1-esterase inhibitor, then higher-volume placebo
B: Arm Label: Open-label C1INH-nf; Type: EXPERIMENTAL; Interventions: Biological: C1 esterase inhibitor [human] (C1INH-nf) | Intervention Type: BIOLOGICAL; Name: C1 esterase inhibitor [human] (C1INH-nf); Assigned to Arm(s): Open-label C1INH-nf
C: Arm Label: BCX7353 110mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: BCX7353 150mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral capsule | Intervention Type: DRUG; Name: BCX7353 capsules; Assigned to Arm(s): BCX7353 110mg once daily | Intervention Type: DRUG; Name: BCX7353 capsules; Assigned to Arm(s): BCX7353 150mg once daily | Intervention Type: DRUG; Name: Placebo oral capsule; Assigned to Arm(s): Placebo
D: Arm Label: BCX7353 110 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: BCX7353 150 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral capsule | Intervention Type: DRUG; Name: BCX7353 capsules; Assigned to Arm(s): BCX7353 110 mg once daily, BCX7353 150 mg once daily | Intervention Type: DRUG; Name: Placebo oral capsule; Assigned to Arm(s): Placebo

Answer: A