The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.
Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities, and the development of drug resistance mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
300-mg tablet (marketed formulation) taken orally once daily
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Hacienda Heights, California, United States
Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)
Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.
Time frame: Week 48
Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48
Number of participants with normal ALT (at or below the upper limit of normal \[ULN\] for the central laboratory \[34 U/L\])at Week 48
Time frame: Week 48
Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48
A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)
Time frame: Week 48
Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48
Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA \< 400 copies/mL (\<69 IU/mL) and normal ALT (ALT \<= ULN \[34 U/L\]); and with HBV DNA \< 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA \< 400 copies/mL and normal ALT was analyzed.
Time frame: Week 48
Change From Baseline in FibroTest Value
The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Monterey Park, California, United States
Unnamed facility
Mountain View, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
San Jose, California, United States
Unnamed facility
Hamden, Connecticut, United States
Unnamed facility
Baltimore, Maryland, United States
...and 11 more locations
Time frame: Baseline and Week 48
Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion
HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.
Time frame: Week 48
Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48
Blood samples from study participants were collected for measuring HBV DNA via PCR method.
Time frame: Week 48
Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss
Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA \< 400 copies/mL (\<69 IU/mL) and normal ALT (ALT \<= ULN \[34 U/L\]); and with HBV DNA \< 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA \< 400 copies/mL and normal ALT was analyzed.
Time frame: Week 48
Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe
Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA \< 400 copies/mL (\<69 IU/mL) and normal ALT (ALT \<= ULN); and with HBV DNA \< 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA \< 400 copies/mL and normal ALT was analyzed.
Time frame: Week 48
Summary of Resistance Surveillance for Participants Without Virologic Breakthrough
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.
Time frame: Week 48
Summary of Resistance Surveillance for Participants With Virologic Breakthrough
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.
Time frame: Week 48
Summary of Resistance Surveillance for Participants Who Discontinued the Study Early
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.
Time frame: Week 48