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Chronic Hepatitis BPhase 4NCT00736190

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

A Phase 4 study testing Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Tenofovir disoproxil fumarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
21 sitesUnited States
Study dates
Aug 2008to Jul 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 </= 10 × ULN at screening or within the past 12 months prior to screening
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Study site

    Baltimore, Maryland, 21234

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Brooklyn, New York, 11219

  • Study site

    Englewood, New Jersey, 07631

  • Study site

    Fairfax, Virginia, 22030

  • Study site

    Falls Church, Virginia, 22044

  • Study site

    Flushing, New York, 11355

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Hacienda Heights, California, 91745

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Laurel, Maryland, 20707

  • Study site

    Los Angeles, California, 90057

  • Study site

    Monterey Park, California, 91754

  • Study site

    Mountain View, California, 94040

  • Study site

    New York, New York, 10013

  • Study site

    New York, New York, 10038

  • Study site

    Oakland, California, 94609

  • Study site

    Palo Alto, California, 94304

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    San Jose, California, 95128

  • Study site

    Silver Spring, Maryland, 20902

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Tenofovir disoproxil fumarate
Keywords
Hepatitis B, Hepatitis, Tenofovir disoproxil fumarate, Tenofovir DF, Asian-American
Medical subject headings
Hepatitis B, Chronic, Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir disoproxil fumarateDrug

    Also called Viread

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

Study groups in NCT00736190
Study groupRoleWhat they receive
TDFExperimental300-mg tablet (marketed formulation) taken orally once daily
Receives: Drug: Tenofovir disoproxil fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (11)

  1. 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

    Measured: Week 48

  2. 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)

    Measured: Week 48

  3. 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.

    Measured: Week 48

  4. 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.

    Measured: Baseline and Week 48

  5. 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.

    Measured: Week 48

  6. 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.

    Measured: Week 48

  7. 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.

    Measured: Week 48

  8. 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.

    Measured: Week 48

  9. 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.

    Measured: Week 48

  10. 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.

    Measured: Week 48

  11. 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.

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00736190
Sponsor's protocol ID
GS-US-174-0123
Status last verified
Nov 2011
First submitted
13 Aug 2008
Last updated
5 Dec 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 25987775

  • 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.

    PubMed 24594870

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00736190, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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