Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

Completed · Phase 4

Conditions studied: Chronic Hepatitis B

In brief

The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg). The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

Key facts

Study ID

NCT01277601

Run by

Gilead Sciences

People needed

751

Starts

2011-04-01

Expected to finish

2015-07-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
• Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
• Positive or negative for hepatitis B e antigen (HBeAg)
• HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
• Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
• Creatinine clearance ≥ 70 mL/min
• Negative serum pregnancy test for females of childbearing potential
• Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
• Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product

You may not qualify if…

• Known bridging fibrosis or cirrhosis and/or decompensated liver disease
• Evidence of hepatocellular carcinoma
• Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
• Absolute neutrophil count < 1,500/mm\^3, platelet < 100,000/mm\^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
• History of severe depression or severe psychiatric disease
• Thyroid dysfunction
• Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
• Pregnant

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Research and Education Inc — San Diego, California, United States
• San Jose Gastroenterology — San Jose, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Centre for Advanced Gastroenterology — Maitland, Florida, United States
• University of Miami / Jackson Memorial Medical Center — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• LSU Gastroenterology/Center for Digestive Diseases — New Orleans, Louisiana, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• Digestive Disease Associates — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• ID Care, Inc. — Hillsborough, New Jersey, United States
• Medical Procare, PLLC — Flushing, New York, United States
• North Shore University Hospital — Great Neck, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• New York Univ. Medical Center — New York, New York, United States
• Weill Cornell Medical College of Cornell University — New York, New York, United States
• Private Practice — Philadelphia, Pennsylvania, United States
• Advanced Liver Therapies at St. Luke's Episcopal Hospital — Houston, Texas, United States
• Kelsey Research Foundation — Houston, Texas, United States
• Liver Associates of Texas, — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Liver Institute of Virginia, Bon Secours Health System — Richmond, Virginia, United States
• Asian Pacific Liver Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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