Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-label, Randomized Study to Evaluate the Long-term Clinical Safety and Efficacy 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 long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.


Options:
A: 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
B: Arm Label: C1-INH - low-volume dose; Type: EXPERIMENTAL; Interventions: Biological: C1-esterase inhibitor | Arm Label: C1-INH - medium-volume dose; Type: EXPERIMENTAL; Interventions: Biological: C1-esterase inhibitor | Intervention Type: BIOLOGICAL; Name: C1-esterase inhibitor; Assigned to Arm(s): C1-INH - low-volume dose, C1-INH - medium-volume dose
C: Arm Label: C1INH-nf First, then Placebo; Type: EXPERIMENTAL; Interventions: Biological: C1 esterase inhibitor [human] (C1INH-nf), Drug: Placebo (saline) | Arm Label: Placebo First, then C1INH-nf; Type: EXPERIMENTAL; Interventions: Biological: C1 esterase inhibitor [human] (C1INH-nf), Drug: Placebo (saline) | Intervention Type: BIOLOGICAL; Name: C1 esterase inhibitor [human] (C1INH-nf); Assigned to Arm(s): C1INH-nf First, then Placebo, Placebo First, then C1INH-nf | Intervention Type: DRUG; Name: Placebo (saline); Assigned to Arm(s): C1INH-nf First, then Placebo, Placebo First, then C1INH-nf
D: Arm Label: DX-2930, Cohort 1; Type: EXPERIMENTAL; Interventions: Drug: DX-2930 | Arm Label: DX-2930, Cohort 2; Type: EXPERIMENTAL; Interventions: Drug: DX-2930 | Arm Label: DX-2930, Cohort 3; Type: EXPERIMENTAL; Interventions: Drug: DX-2930 | Arm Label: DX-2930, Cohort 4; Type: EXPERIMENTAL; Interventions: Drug: DX-2930 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: DX-2930; Assigned to Arm(s): DX-2930, Cohort 1, DX-2930, Cohort 2, DX-2930, Cohort 3, DX-2930, Cohort 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B