A Randomized, Open-Label Study to Evaluate the

INTERVENTION: Product Name: ABT‐450 Pharmaceutical Form: Tablet INN or Proposed INN: Not available Current Sponsor code: ABT‐450 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Product Name: ABT‐267 Pharmaceutical Form: Tablet INN or Proposed INN: Not available Current Sponsor code: ABT‐267 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: Norvir 100 mg soft capsules Pharmaceutical Form: Capsule, soft INN or Proposed INN: RITONAVIR CAS Number: 155213‐67‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Product Name: Ribavirin Product Code: Ribavirin Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: RIBAVIRIN CAS Number: 36791‐04‐5 Current Sponsor code: RIBAVIRIN Other descriptive name: RIBAVIRIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ CONDITION: Chronic Hepatitis C Infection ; MedDRA version: 16.0 Level: PT Classification code 10008909 Term: Chronic hepatitis System Organ Class: 10019805 ‐ Hepatobiliary disorders Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: The primary objective is to assess the safety and efficacy (the percentage of subjects with HCV RNA

Epistemonikos ID: 2068893c1ce7591665c3f35dab2f76be434171de
First added on: Aug 22, 2024