Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Completed · Phase 3

Conditions studied: Hepatitis C Virus

In brief

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.

Key facts

Study ID

NCT01573351

Run by

Bristol-Myers Squibb

People needed

398

Starts

2012-05-01

Expected to finish

2013-12-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ≥ 18 years of age
• HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
• HCV RNA ≥ 10,000 IU/mL
• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
• Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

You may not qualify if…

• Prior treatment of HCV with HCV direct acting antiviral (DAA)
• Evidence of a medical condition contributing to chronic liver disease other than HCV
• Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
• Diagnosed or suspected hepatocellular carcinoma or other malignancies
• Uncontrolled diabetes or hypertension
• Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
• Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
• Albumin < 3.5 g/dL (35 g/L)
• Alpha Fetoprotein (AFP) > 100 ng/mL (>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
• Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
• Platelets < 90 x 1000,000,000 cells/L
• Hemoglobin < 12 g/dL for females or < 13 g/dL for males
• Any criteria that would exclude the subject from receiving P/R

Where it is running

• Scripps Clinic — La Jolla, California, United States
• Scpmg/ Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• University Of Colorado Denver And Hospital — Aurora, Colorado, United States
• South Denver Gastroenterology, Pc — Englewood, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University Of Miami Schiff Center For Liver Diseases — Miami, Florida, United States
• University Of Chicago Medical Center — Chicago, Illinois, United States
• North Shore University Hospital — Manhasset, New York, United States
• University Of North Carolina At Chapel Hill School Of Med — Chapel Hill, North Carolina, United States
• University Of Cincinnati — Cincinnati, Ohio, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Gastro One — Germantown, Tennessee, United States
• Baylor College Of Medicine — Houston, Texas, United States
• Texas Liver Institute — San Antonio, Texas, United States
• Mcguire Dvamc — Richmond, Virginia, United States
• Dean Clinic — Madison, Wisconsin, United States
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Prov. Buenos Aires, Buenos Aires, Argentina
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Vancouver, British Columbia, Canada
• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.