Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
Brief Summary: This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
* Cohort B: post-liver transplant, with or without cirrhosis;
* Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
* Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.


Options:
A: Arm Label: Healthy control; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Metastatic liver cancer patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Hepatocellular carcinoma patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Chronic liver disease patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Intervention Type: DIAGNOSTIC_TEST; Name: PIVKA-II; Assigned to Arm(s): Chronic liver disease patients, Healthy control, Hepatocellular carcinoma patients, Metastatic liver cancer patients
B: Arm Label: Triphasic CT; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Screening | Arm Label: Ultrasound; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Screening | Intervention Type: PROCEDURE; Name: Screening; Assigned to Arm(s): Triphasic CT, Ultrasound
C: Arm Label: Cohort A, Group 1 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 1 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (12 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (24 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (12 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (24 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (12 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (24 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH
D: Arm Label: LDV/SOF; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: Placebo to match RBV | Arm Label: LDV/SOF + RBV; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV, Drug: Placebo to match LDV/SOF, Drug: Placebo to match RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match LDV/SOF; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV

Answer: C