Phase 4
Completed N=90
A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection
Source: ClinicalTrials.gov NCT00736190 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) — 74 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) |
74 | — |
| SECONDARY Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48 |
59 | — |
| SECONDARY Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48 |
40 | — |
| SECONDARY Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48 |
55 | — |
| SECONDARY Change From Baseline in FibroTest Value |
-0.006 | — |
| SECONDARY Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion |
90; 0; 88; 2; 53; 37 | — |
| SECONDARY Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48 |
73 | — |
| SECONDARY Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss |
— | — |
| SECONDARY Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe |
— | — |
| SECONDARY Summary of Resistance Surveillance for Participants Without Virologic Breakthrough |
6; 1; 2; 1 | — |
| SECONDARY Summary of Resistance Surveillance for Participants With Virologic Breakthrough |
2; 0; 0; 0 | — |
| SECONDARY Summary of Resistance Surveillance for Participants Who Discontinued the Study Early |
1; 0; 0; 1 | — |
Eligibility Criteria
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 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 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 12 weeks of oral anti-HBV nucleoside/nucleotide therapy, or receipt of ANY oral anti-HBV treatment 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
Data sourced from ClinicalTrials.gov (NCT00736190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.