DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Tenofovir disoproxil fumarate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gilead Sciences


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.

Clinical Details

Official title: A Phase IV Study to Evaluate the Efficacy, Safety and Tolerability of Tenofovir DF in Asian-American Adults With Chronic Hepatitis B Infection

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)

Secondary outcome:

Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48

Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at 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

Change From Baseline in FibroTest Value

Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion

Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48

Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss

Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe

Summary of Resistance Surveillance for Participants Without Virologic Breakthrough

Summary of Resistance Surveillance for Participants With Virologic Breakthrough

Summary of Resistance Surveillance for Participants Who Discontinued the Study Early

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female

- Asian-American, defined as a person of self-reported Asian ancestry who is residing

in the United States (US)

- 18 through 75 years of age, inclusive

- Documented chronic HBV infection, defined as positive serum HBsAg =/> 6 months

- HBV DNA =/> 10,000 copies/mL (PCR method)

- ALT > ULN and screening

- Willing and able to provide written informed consent

- Negative serum beta-human chorionic gonadotropin (HCG) pregnancy test (females of

child-bearing potential)

- Estimated glomerular filtration rate (creatinine clearance) =/> 60 mL/min/1. 73m^2 by

the Cockcroft-Gault equation

- Adequate hematologic function (absolute neutrophil count =/> 1,500/mm^3; hemoglobin

=/> 10. 0 g/dL)

- No prior TDF therapy; participants may have taken < 12 weeks of oral anti-HBV

therapy, with the last dose =/> 16 weeks prior to screening; participants may have received prior interferon, but must have discontinued interferon therapy =/> 6 months prior to screening Exclusion Criteria: Participants who meet any of the following exclusion criteria are not to be enrolled in this study.

- Pregnant women, women who are breast feeding or who believe they may wish to become

pregnant during the course of the study.

- Males and females of reproductive potential who are not willing to use an effective

method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.

- Decompensated liver disease defined as direct (conjugated) bilirubin > 1. 2 X ULN,

prothrombin time (PT) > 1. 2 X ULN, platelets < 150,000/mm3, or serum albumin < 3. 5 g/dL

- Prior history of clinical hepatic decompensation (eg, ascites, jaundice,

encephalopathy) or variceal hemorrhage

- Receipt of prior TDF treatment

- Receipt of =/> 12 weeks of oral anti-HBV nucleoside/nucleotide therapy, or receipt of

ANY oral anti-HBV treatment < 16 weeks prior to screening

- Receipt of interferon (pegylated or not) therapy within 6 months of the Screening


- alpha-fetoprotein > 50 ng/mL

- Evidence of hepatocellular carcinoma (HCC)

- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or

hepatitis D virus (HDV)

- History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis,

polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)

- History of significant bone disease (eg, osteomalacia, chronic osteomyelitis,

osteogenesis imperfecta, osteochrondroses, multiple bone fractures)

- Significant cardiovascular, pulmonary or neurological disease

- Evidence of a gastrointestinal malabsorption syndrome that may interfere with

absorption of orally administered medications

- History of solid organ or bone marrow transplantation

- Ongoing therapy with any of the following: nephrotoxic agents, competitors of renal

excretion (eg, probenecid), systemic chemotherapeutic agents, systemic corticosteroids, Interleukin-2 (IL-2) and other immunomodulating agents, investigational agents (except with the expressed approval of the Sponsor); administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period

- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients

- Any other condition (including alcohol or substance abuse) or prior therapy that, in

the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements

Locations and Contacts

Fountain Valley, California 92708, United States

Hacienda Heights, California 91745, United States

Los Angeles, California 90057, United States

Monterey Park, California 91754, United States

Mountain View, California 94040, United States

Oakland, California 94609, United States

Palo Alto, California 94304, United States

San Jose, California 95128, United States

Hamden, Connecticut 06518, United States

Baltimore, Maryland 21234, United States

Laurel, Maryland 20707, United States

Silver Spring, Maryland 20902, United States

Englewood, New Jersey 07631, United States

Brooklyn, New York 11219, United States

Flushing, New York 11355, United States

New York, New York 10038, United States

New York, New York 10013, United States

Philadelphia, Pennsylvania 19107, United States

Fairfax, Virginia 22030, United States

Falls Church, Virginia 22044, United States

Bellevue, Washington 98004, United States

Additional Information

Starting date: August 2008
Last updated: November 30, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017