NCT01435044

Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
DRUG	GS-0938	GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
DRUG	RBV	Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	Placebo to match sofosbuvir	Placebo to match sofosbuvir administered orally once daily
DRUG	Placebo to match GS-0938	Placebo to match GS-0938 administered orally once daily

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2011-09-15
• Last updated: 2014-02-06

Locations

44 sites across 2 countries: United States, Puerto Rico