Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \< the lower limit of quantitation (LLOQ), or achieved HCV RNA \< LLOQ).


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: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1
C: 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
D: 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

Answer: C