Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Aug 2008

Geographic Reach

1 country

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

August 1, 2008

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2011

Completed

Last Updated

December 5, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

August 13, 2008

Results QC Date

July 7, 2011

Last Update Submit

November 30, 2011

Conditions

Chronic Hepatitis B

Keywords

Hepatitis BHepatitisTenofovir disoproxil fumarateTenofovir DFAsian-American

Outcome Measures

Primary Outcomes (1)

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.
Week 48

Secondary Outcomes (11)

Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48
Week 48
Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48
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
Week 48
Change From Baseline in FibroTest Value
Baseline and Week 48
Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion
Week 48
+6 more secondary outcomes

Study Arms (1)

TDF

EXPERIMENTAL

300-mg tablet (marketed formulation) taken orally once daily

Drug: Tenofovir disoproxil fumarate

Interventions

Tenofovir disoproxil fumarateDRUG

300-mg tablet (marketed formulation) taken orally once daily

Also known as: Viread

TDF

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female
Asian-American, defined as a person of self-reported Asian ancestry who is residing in the United States (US)
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 \</= 10 × ULN at screening or within the past 12 months prior to 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

You may not qualify if:

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 Visit
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
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Gilead Scienceslead

Study Sites (21)

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

Hacienda Heights, California, 91745, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Monterey Park, California, 91754, United States

Location

Unknown Facility

Mountain View, California, 94040, United States

Location

Unknown Facility

Oakland, California, 94609, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

San Jose, California, 95128, United States

Location

Unknown Facility

Hamden, Connecticut, 06518, United States

Location

Unknown Facility

Baltimore, Maryland, 21234, United States

Location

Unknown Facility

Laurel, Maryland, 20707, United States

Location

Unknown Facility

Silver Spring, Maryland, 20902, United States

Location

Unknown Facility

Englewood, New Jersey, 07631, United States

Location

Unknown Facility

Brooklyn, New York, 11219, United States

Location

Unknown Facility

Flushing, New York, 11355, United States

Location

Unknown Facility

New York, New York, 10013, United States

Location

Unknown Facility

New York, New York, 10038, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Fairfax, Virginia, 22030, United States

Location

Unknown Facility

Falls Church, Virginia, 22044, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

Related Publications (2)

Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524.
PMID: 25987775DERIVED
Pan CQ, Trinh H, Yao A, Bae H, Lou L, Chan S; Study 123 Group. Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings. PLoS One. 2014 Mar 4;9(3):e89789. doi: 10.1371/journal.pone.0089789. eCollection 2014.
PMID: 24594870DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BHepatitis

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Eduardo Bruno Martins, MD, DPhil, Sr. Director, Medical Affairs - Hepatitis
Organization: Gilead Sciences, Inc.

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 5, 2011

Results First Posted

August 3, 2011

Record last verified: 2011-11

Locations

US(21)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

TDF

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Locations