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

Hepatitis C, Chronic Clinical Trial

— QUANTUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435044
• Other study ID #: P2938-0721
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2011
• Last updated: January 7, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic HCV-infection

• Naive to all HCV antiviral treatment

• Otherwise healthy patients

Exclusion Criteria:

• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab

• History of any other clinically significant chronic liver disease

• Medical history which the investigator considers the patient unsuitable for the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
• GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
• 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)
• Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
• Placebo to match GS-0938
Placebo to match GS-0938 administered orally once daily

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Investigative Clinical Research	Annapolis	Maryland
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Ashville Gastroenterology Associates	Ashville	North Carolina
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Avail Clinical Research	Deland	Florida
United States	Digestive Health Services	Downers Grove	Illinois
United States	South Denver Gastroenterology	Englewood	Colorado
United States	University of Florida Hepatology	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	ID Care	Hillsborough	New Jersey
United States	CLI	Los Angeles	California
United States	University of Miami Center for Liver Diseases	Miami	Florida
United States	Alabama Liver & Digestive Specialists	Montgomery	Alabama
United States	Nashville Gastrointestinal Specialists	Nashville	Tennessee
United States	Concorde Medical Group	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Internal Medicine Specialists	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Alamo Medical Research	San Antonio	Texas
United States	eStudy Site	San Diego	California
United States	Medical Associates Research Group	San Diego	California
United States	UCSD Antiviral Research Center	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Miami Research Associates	South Miami	Florida
United States	Carolina's Center for Liver Disease	Statesville	North Carolina
United States	Advanced Research Institute	Trinity	Florida
United States	South Florida Center of Gastroenterology	Wellington	Florida
United States	Digestive Health Specialists	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)	SVR12 was defined as HCV RNA < LLOQ 12 weeks after the last dose of all study drugs.	Post-treatment Week 12	No
Secondary	Percentage of Participants Who Experienced Adverse Events	Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.	Baseline to Week 24 plus 30 days	No
Secondary	Change from baseline in HCV RNA		Baseline to Week 12	No
Secondary	Percentage of Participants With HCV RNA < LLOQ during treatment		Baseline to Week 12	No
Secondary	Percentage of Participants With ALT Normalization	ALT normalization was defined as ALT > ULN at baseline and ALT = ULN at a subsequent visit.	Baseline to post-treatment Week 4	Yes
Secondary	Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)	SVR4 and SVR24 was defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.	Post-treatment Weeks 4 and 24	Yes
Secondary	Percentage of Participants Who Developed Resistance to Sofosbuvir		Baseline to Week 24	No