Chronic Hepatitis BPhase 3NCT00116805
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
A Phase 3 study testing TDF, ADV and FTC/TDF in people with Chronic Hepatitis B, run by Gilead Sciences at 87 sites in 15 countries.
Trial summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TDF, ADV and FTC/TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 87 sitesin 15 countries
- Study dates
- Jun 2005to Jan 2016
- Phase
- Phase 3
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet all of the following inclusion criteria to be eligible for participation in this study:
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
- 18 through 69 years of age, inclusive
- Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
- HBeAg positive at screening
- Alanine aminotransferase (ALT) levels > 2 × ULN and ≤ 10 × the upper limit of the normal range (ULN)
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- Serum HBV DNA > 1 million copies/mL at screening
- creatinine clearance ≥ 70 mL/min
- hemoglobin ≥ 8 g/dL
- neutrophils ≥ 1,000 /mL
- Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score < 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
- Negative serum β-human chorionic gonadotropin (hCG)
- Nucleotide naïve, ie, no prior nucleotide (TDF or ADV) therapy for > 12 weeks
- Nucleoside naïve, ie, no prior nucleoside (any nucleoside) therapy for > 12 weeks
- Willing and able to provide written informed consent
- Liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
Who cannot join
- A patient who meets any of the following exclusion criteria is 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 unwilling 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
- Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre-treatment biopsy
- Evidence of hepatocellular carcinoma (HCC), ie, α-fetoprotein >50 ng/mL
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- Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV)
- Significant renal, cardiovascular, pulmonary, or neurological disease
- Received solid organ or bone marrow transplantation
- Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
- Has proximal tubulopathy
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
87 sites in 15 countries.
87 sites in 15 countries
United States20 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30309
Study site
Baltimore, Maryland, 21229
Study site
Detroit, Michigan, 48202
Study site
Fairfax, Virginia, 22031
Study site
Falls Church, Virginia, 22042
Study site
Flushing, New York, 11355
Study site
Honolulu, Hawaii, 96817
Study site
Miami, Florida, 33136
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
New York, New York, 10032
Study site
Orange, California, 92868
Study site
Pasadena, California, 91105
Study site
Richmond, Virginia, 23298
Study site
San Diego, California, 92105
Study site
San Jose, California, 95116
Study site
Seattle, Washington, 98101
Study site
St Louis, Missouri, 63104
Germany12 sites
Study site
Berlin, 10969
Study site
Düsseldorf, 40225
Study site
Düsseldorf, 40237
Study site
Essen, 45122
Study site
Hamburg, 20099
Study site
Hanover, 30623
Study site
Herne, 44623
Study site
Homburg/Saar, 66421
Study site
Kiel, 24105
Study site
Mainz, 55131
Study site
München, 81377
Study site
Tübingen, 72076
Australia10 sites
Study site
Camperdown, New South Wales, 2050
Study site
Clayton, Victoria, 3168
Study site
Concord, New South Wales, 2139
Study site
Fitzroy, 3065
Study site
Footscray, Victoria, 3011
Study site
Parkville, Victoria, 3050
Study site
Perth, 6000
Study site
Prahran, Victoria, 3004
Study site
Westmead, New South Wales, 2145
Study site
Woolloongabba, Queensland, 4102
France7 sites
Study site
Clichy, 92110
Study site
Grenoble, 38043
Study site
Lille, 59037
Study site
Lyon, 69317
Study site
Nancy, 54500
Study site
Paris, 75651
Study site
Strasbourg, 67901
Poland7 sites
Study site
Bialystok, 15-540
Study site
Bydgoszcz, 85-030
Study site
Chorzów, 41-500
Study site
Kielce, 25-317
Study site
Krakow, 31-501
Study site
Warsaw, 01-201
Study site
Wroclaw, 50-136
Canada5 sites
Study site
Calgary, Alberta, T2N4Z6
Study site
Toronto, Ontario, M5G 2C4
Study site
Toronto, Ontario, M5T 2S8
Study site
Vancouver, British Columbia, V5Z1H2
Study site
Winnepeg, Manitoba, R3E3P4
Czechia4 sites
Study site
Brno, 62500
Study site
Hradec Králové
Study site
Prague, 140 21
Study site
Praha 6- Stresovice, 169 02
New Zealand4 sites
Study site
Auckland
Study site
Hamilton
Study site
Wellington
Study site
Whakatane
Spain4 sites
Study site
Barcelona, 08025
Study site
Barcelona, 08035
Study site
Barcelona, 08907
Study site
Valencia, 46009
Turkey (Türkiye)4 sites
Study site
Ankara, 06100
Study site
Bursa
Study site
Istanbul
Study site
Izmir
Bulgaria3 sites
Study site
Sofia, 1407
Study site
Sofia, 1431
Study site
Varna, 9010
Greece3 sites
Study site
Athens, 11526
Study site
Thessaloniki, 54642
Study site
Thessaloniki, 56429
United Kingdom2 sites
Study site
Birmingham, B15 2TH
Study site
London, NW1 2BU
About this study
Official title: A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- TDF, ADV, TDF placebo, ADV placebo, FTC/TDF
- Keywords
- tenofovir, adefovir, hepatitis B, HBeAg Positive
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDFDrug
Also called Viread®
300 mg tablet administered orally once daily
ADVDrug
Also called Hepsera®
10 mg tablet administered orally once daily
TDF placeboDrug
Tablet administered orally once daily
ADV placeboDrug
Tablet administered orally once daily
FTC/TDFDrug
Also called Truvada®
200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| TDF-TDF | Experimental | TDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. Receives: Drug: TDF; Drug: ADV placebo; Drug: FTC/TDF |
| ADV-TDF | Active comparator | ADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period. Receives: Drug: TDF; Drug: ADV; Drug: TDF placebo; Drug: FTC/TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48
Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.
A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40.
Measured: Baseline; Week 48
Secondary outcomes (33)
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48
Measured: Week 48
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96
Measured: Week 96
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384
Measured: Weeks 144, 192, 240, 288, 336, and 384
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480
Measured: Weeks 432 and 480
Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Measured: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Measured: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Percentage of Participants With Histological Response at Week 48
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.
Measured: Baseline; Week 48
Percentage of Participants With Histological Response at Week 240
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.
Measured: Baseline; Week 240
Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).
Measured: Baseline; Week 48
Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).
Measured: Baseline; Week 240
Ranked Assessment of Necroinflammation and Fibrosis at Week 48
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.
Measured: Baseline; Week 48
Ranked Assessment of Necroinflammation and Fibrosis at Week 240
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.
Measured: Baseline; Week 240
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Measured: Baseline; Week 48
Percentage of Participants With ALT Normalization at Week 96
ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Measured: Baseline; Week 96
Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Measured: Baseline; Weeks 144, 192, 240, 288, 336, and 384
Percentage of Participants With ALT Normalization at Weeks 432 and 480
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.
Measured: Baseline; Weeks 432 and 480
Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Measured: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Measured: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48.
Measured: Baseline; Week 48
Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96.
Measured: Baseline; Week 96
Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.
Measured: Baseline; Week 48
Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.
Measured: Baseline; Week 96
Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.
Measured: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.
Measured: Baseline; Week 48
Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 49 to 96
Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 97 to 144
Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 145 to 192
Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 193 to 240
Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 241 to 288
Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 289 to 336
Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 337 to 384
Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 385 to 432
Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.
Measured: Baseline; Weeks 433 to 480
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionMay 2007
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116805
- Sponsor's protocol ID
- GS-US-174-0103
- Other IDs
- 2004-005120-41, 2004
- Status last verified
- Jan 2017
- First submitted
- 30 Jun 2005
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kitrinos KM, Corsa A, Liu Y, Flaherty J, Snow-Lampart A, Marcellin P, Borroto-Esoda K, Miller MD. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology. 2014 Feb;59(2):434-42. doi: 10.1002/hep.26686.
PubMed 23939953Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.
PubMed 23234725Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.
PubMed 23364953Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, Trinh H, Flaherty JF, Kitrinos KM, Dinh P, Charuworn P, Subramanian GM, Gane E. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B. Dig Dis Sci. 2015 Jan;60(1):260-8. doi: 10.1007/s10620-014-3336-7. Epub 2014 Sep 2.
PubMed 25179493Fung S, Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Gane E, Jacobson IM, Yee LJ, Dinh P, Martins EB, Flaherty JF, Kitrinos KM, Dusheiko G, Trinh H, Flisiak R, Rustgi VK, Buti M, Marcellin P. Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (>/= 9 log10 copies/ml). Liver Int. 2015 Feb;35(2):422-8. doi: 10.1111/liv.12694. Epub 2014 Oct 28.
PubMed 25277773Marcellin P, Buti M, Krastev Z, de Man RA, Zeuzem S, Lou L, Gaggar A, Flaherty JF, Massetto B, Lin L, Dinh P, Subramanian GM, McHutchison JG, Flisiak R, Gurel S, Dusheiko GM, Heathcote EJ. Kinetics of hepatitis B surface antigen loss in patients with HBeAg-positive chronic hepatitis B treated with tenofovir disoproxil fumarate. J Hepatol. 2014 Dec;61(6):1228-37. doi: 10.1016/j.jhep.2014.07.019. Epub 2014 Jul 18.
PubMed 25046847Buti M, Fung S, Gane E, Afdhal NH, Flisiak R, Gurel S, Flaherty JF, Martins EB, Yee LJ, Dinh P, Bornstein JD, Mani Subramanian G, Janssen HL, George J, Marcellin P. Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years. Hepatol Int. 2015 Apr;9(2):243-50. doi: 10.1007/s12072-015-9614-4. Epub 2015 Mar 13.
PubMed 25788199Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, Aguilar Schall R, Flaherty JF, Martins EB, Charuworn P, Kitrinos KM, Subramanian GM, Gane E, Marcellin P. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci. 2015 May;60(5):1457-64. doi: 10.1007/s10620-014-3486-7. Epub 2014 Dec 23.
PubMed 25532501Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, Kitrinos KM, Marcellin P, Gane EJ. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat. 2017 Jan;24(1):68-74. doi: 10.1111/jvh.12613. Epub 2016 Sep 23.
PubMed 27658343Corsa A, Liu Y, Flaherty JF, Marcellin P, Miller M, Kitrinos KM. No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) in HBeAg+ and HBeAg- Patients With Chronic Hepatitis B (CHB) After Eight Years of Treatment [Abstract 1707]. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 08-10 November; Boston MA.
Marcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gurel S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials [Abstract]. 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston, MA.
Gane EJ, Marcellin P, Sievert W, Trinh HN, Shiffman ML, Washington MK, et al. Five years of Treatment with Tenofovir DF for Chronic Hepatitis B Infection in Asian Patients is Associated with Sustained Viral Suppression and Significant Regression of Histological Fibrosis and Cirrhosis [Poster Number 1429]. 62nd Annual Meeting of the American Association for the Study of Liver Diseases; 2011 November 4-8; San Francisco, California.
Marcellin P, Wong DK, Sievert W, Buggisch P, Petersen J, Flisiak R, Manns M, Kaita K, Krastev Z, Lee SS, Cathcart AL, Crans G, Op den Brouw M, Jump B, Gaggar A, Flaherty J, Buti M. Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection. Liver Int. 2019 Oct;39(10):1868-1875. doi: 10.1111/liv.14155. Epub 2019 Jul 10.
PubMed 31136052Buti M, Wong DK, Gane E, Flisiak R, Manns M, Kaita K, Janssen HLA, Op den Brouw M, Jump B, Kitrinos K, Crans G, Flaherty J, Gaggar A, Marcellin P. Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. Lancet Gastroenterol Hepatol. 2019 Apr;4(4):296-304. doi: 10.1016/S2468-1253(19)30015-9. Epub 2019 Feb 20.
PubMed 30795958Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, Akarca US, Tchernev KG, Flaherty JF, Aguilar Schall R, Myers RP, Subramanian GM, McHutchison JG, Younossi Z, Marcellin P, Patel K. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2. doi: 10.1016/j.cgh.2017.01.032. Epub 2017 Feb 12.
PubMed 28215615
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00116805
- Acronym / sponsor ID
- GS-US-174-0103
- Conditions
- Chronic Hepatitis B
- Keywords
- tenofovir, adefovir, hepatitis B, HBeAg Positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2005 (actual)
- Primary completion
- May 2007 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Jul 2005 (estimated)
- Results
- Posted 19 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF-TDF | Experimental | Drug: TDF, Drug: ADV placebo, Drug: FTC/TDFTDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. |
| ADV-TDF | Active comparator | Drug: TDF, Drug: ADV, Drug: TDF placebo, Drug: FTC/TDFADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A patient must meet all of the following inclusion criteria to be eligible for participation in this study:
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
- 18 through 69 years of age, inclusive
- Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
- Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score < 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
Key exclusion criteria (12 listed)
- A patient who meets any of the following exclusion criteria is 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 unwilling 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
- Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre-treatment biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDFAlso: Viread®300 mg tablet administered orally once daily | Drug | ADV-TDF, TDF-TDF |
| ADVAlso: Hepsera®10 mg tablet administered orally once daily | Drug | ADV-TDF |
| TDF placeboTablet administered orally once daily | Drug | ADV-TDF |
| ADV placeboTablet administered orally once daily | Drug | TDF-TDF |
| FTC/TDFAlso: Truvada®200/300 mg fixed-dose combination (FDC) tablet administered orally once daily | Drug | ADV-TDF, TDF-TDF |
Primary outcome
Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48
Time frame: Baseline; Week 48
Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40.
33 secondary outcomes
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384
Time frame: Weeks 144, 192, 240, 288, 336, and 384
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480
Time frame: Weeks 432 and 480
Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Time frame: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Time frame: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Percentage of Participants With Histological Response at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With Histological Response at Week 240
Time frame: Baseline; Week 240
Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240
Time frame: Baseline; Week 240
Ranked Assessment of Necroinflammation and Fibrosis at Week 48
Time frame: Baseline; Week 48
Ranked Assessment of Necroinflammation and Fibrosis at Week 240
Time frame: Baseline; Week 240
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With ALT Normalization at Week 96
Time frame: Baseline; Week 96
Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384
Time frame: Baseline; Weeks 144, 192, 240, 288, 336, and 384
Percentage of Participants With ALT Normalization at Weeks 432 and 480
Time frame: Baseline; Weeks 432 and 480
Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Time frame: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Time frame: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96
Time frame: Baseline; Week 96
Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96
Time frame: Baseline; Week 96
Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480
Time frame: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)
Time frame: Baseline; Week 48
Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)
Time frame: Baseline; Weeks 49 to 96
Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)
Time frame: Baseline; Weeks 97 to 144
Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)
Time frame: Baseline; Weeks 145 to 192
Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)
Time frame: Baseline; Weeks 193 to 240
Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)
Time frame: Baseline; Weeks 241 to 288
Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)
Time frame: Baseline; Weeks 289 to 336
Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)
Time frame: Baseline; Weeks 337 to 384
Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)
Time frame: Baseline; Weeks 385 to 432
Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)
Time frame: Baseline; Weeks 433 to 480
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23939953Kitrinos KM, Corsa A, Liu Y, Flaherty J, Snow-Lampart A, Marcellin P, Borroto-Esoda K, Miller MD. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology. 2014 Feb;59(2):434-42. doi: 10.1002/hep.26686.
- Results publication: PubMed 23234725Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.
- Results publication: PubMed 23364953Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.
- Results publication: PubMed 25179493Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, Trinh H, Flaherty JF, Kitrinos KM, Dinh P, Charuworn P, Subramanian GM, Gane E. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B. Dig Dis Sci. 2015 Jan;60(1):260-8. doi: 10.1007/s10620-014-3336-7. Epub 2014 Sep 2.
- Results publication: PubMed 25277773Fung S, Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Gane E, Jacobson IM, Yee LJ, Dinh P, Martins EB, Flaherty JF, Kitrinos KM, Dusheiko G, Trinh H, Flisiak R, Rustgi VK, Buti M, Marcellin P. Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (>/= 9 log10 copies/ml). Liver Int. 2015 Feb;35(2):422-8. doi: 10.1111/liv.12694. Epub 2014 Oct 28.
- Results publication: PubMed 25046847Marcellin P, Buti M, Krastev Z, de Man RA, Zeuzem S, Lou L, Gaggar A, Flaherty JF, Massetto B, Lin L, Dinh P, Subramanian GM, McHutchison JG, Flisiak R, Gurel S, Dusheiko GM, Heathcote EJ. Kinetics of hepatitis B surface antigen loss in patients with HBeAg-positive chronic hepatitis B treated with tenofovir disoproxil fumarate. J Hepatol. 2014 Dec;61(6):1228-37. doi: 10.1016/j.jhep.2014.07.019. Epub 2014 Jul 18.
- Results publication: PubMed 25788199Buti M, Fung S, Gane E, Afdhal NH, Flisiak R, Gurel S, Flaherty JF, Martins EB, Yee LJ, Dinh P, Bornstein JD, Mani Subramanian G, Janssen HL, George J, Marcellin P. Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years. Hepatol Int. 2015 Apr;9(2):243-50. doi: 10.1007/s12072-015-9614-4. Epub 2015 Mar 13.
- Results publication: PubMed 25532501Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, Aguilar Schall R, Flaherty JF, Martins EB, Charuworn P, Kitrinos KM, Subramanian GM, Gane E, Marcellin P. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci. 2015 May;60(5):1457-64. doi: 10.1007/s10620-014-3486-7. Epub 2014 Dec 23.
- Results publication: PubMed 27658343Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, Kitrinos KM, Marcellin P, Gane EJ. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat. 2017 Jan;24(1):68-74. doi: 10.1111/jvh.12613. Epub 2016 Sep 23.
- Results publicationCorsa A, Liu Y, Flaherty JF, Marcellin P, Miller M, Kitrinos KM. No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) in HBeAg+ and HBeAg- Patients With Chronic Hepatitis B (CHB) After Eight Years of Treatment [Abstract 1707]. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 08-10 November; Boston MA.
- Results publicationMarcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gurel S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials [Abstract]. 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston, MA.
- Results publicationGane EJ, Marcellin P, Sievert W, Trinh HN, Shiffman ML, Washington MK, et al. Five years of Treatment with Tenofovir DF for Chronic Hepatitis B Infection in Asian Patients is Associated with Sustained Viral Suppression and Significant Regression of Histological Fibrosis and Cirrhosis [Poster Number 1429]. 62nd Annual Meeting of the American Association for the Study of Liver Diseases; 2011 November 4-8; San Francisco, California.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
87 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TDF, ADV and FTC/TDF in people with Chronic Hepatitis B, run by Gilead Sciences at 87 sites in 15 countries.
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 16 inclusion and 12 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Germany, Australia, France, Poland and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 May 2010). 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?
Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48 (time frame: Baseline; 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 NCT00116805, which also lists 19 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 9 Mar 2017.