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Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Not Recruiting
Trial ID: NCT01277601
Purpose
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.
Official Title
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Intervention(s):
drug: TDF
drug: Peg-IFN
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie Nguyen, MD
650-498-7878