Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00734162
First received: August 13, 2008
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.

The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients < 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents.

This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. One hundred TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, all participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.


Condition Intervention Phase
Hepatitis B Virus (HBV)
Drug: Tenofovir disoproxil fumarate (TDF)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents With Chronic Hepatitis B Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 400 Copies/mL at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

    The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.

    In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included.


  • Number of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: Yes ]
    The number of participants with at least a 6% decrease from baseline in spine BMD at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis).


Secondary Outcome Measures:
  • Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with HBV DNA < 400 copies/mL at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With HBV DNA < 169 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with HBV DNA < 169 copies/mL at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With HBV DNA < 169 Copies/mL at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with HBV DNA < 169 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with normal ALT at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Normal ALT was defined as having a value less than or equal to the upper limit of normal range (ULN).

  • Percentage of Participants With Normal ALT at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with normal ALT at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with abnormal ALT at baseline who had normalized ALT at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Normalized ALT was defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.

  • Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with abnormal ALT at baseline who had normalized ALT at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with both HBV DNA < 400 copies/mL and normal ALT at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with both HBV DNA < 400 copies/mL and normal ALT at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with HBsAg loss at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.

  • Percentage of Participants With HBsAg Loss at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with HBsAg loss at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants with seroconversion to anti-HBs at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.

  • Percentage of Participants With Seroconversion to Anti-HBs at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants with seroconversion to anti-HBs at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBV Early Antigen (HBeAg) Positive at Baseline and Who Had HBeAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBeAg loss at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had HBeAg Loss at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBeAg loss at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had Seroconversion to Antibody Against HBV Early Antigen (Anti-HBe) at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had Seroconversion to Anti-HBe at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBV DNA < 400 copies/mL, normal ALT, and HBeAg Loss at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBV DNA < 400 copies/mL, normal ALT, and HBeAg Loss at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had HBV DNA < 400 Copies/mL, Normal ALT, and Seroconversion to HBeAg at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBV DNA < 400 copies/mL, normal ALT, and seroconversion to HBeAg at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAg Positive at Baseline and Who Had HBV DNA < 400 Copies/mL, Normal ALT, and Seroconversion to HBeAg at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAg positive at baseline and who had HBV DNA < 400 copies/mL, normal ALT, and seroconversion to HBeAg at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Had Abnormal ALT at Baseline and Who Had HBV DNA < 400 Copies/mL and ALT Normalized at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who had abnormal ALT at baseline and who had HBV DNA < 400 copies/mL and ALT normalized at Week 48 was summarized, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Had Abnormal ALT at Baseline and Who Had HBV DNA < 400 Copies/mL and ALT Normalized at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who had abnormal ALT at baseline and who had HBV DNA < 400 copies/mL and ALT normalized at Week 72 was summarized, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAG Positive With Abnormal ALT at Baseline, and Who Had HBV DNA < 400 Copies/mL, ALT Normalized, and HBeAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAG positive with abnormal ALT at baseline, and who had HBV DNA < 400 copies/mL, ALT normalized, and HBeAg loss at Week 48 was summarized, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAG Positive With Abnormal ALT at Baseline, and Who Had HBV DNA < 400 Copies/mL, ALT Normalized, and HBeAg Loss at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAG positive with abnormal ALT at baseline, and who had HBV DNA < 400 copies/mL, ALT normalized, and HBeAg loss at Week 72 was summarized, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAG Positive With Abnormal ALT at Baseline, and Who Had HBV DNA < 400 Copies/mL, ALT Normalized, and Seroconversion to HBeAg at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAG positive with abnormal ALT at baseline, and had HBV DNA < 400 copies/mL, ALT normalized, and seroconversion to HBeAg at Week 48 was summarized, using the M = F analysis with the DBEE algorithm.

  • Percentage of Participants Who Were HBeAG Positive With Abnormal ALT at Baseline, and Who Had HBV DNA < 400 Copies/mL, ALT Normalized, and Seroconversion to HBeAg at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The percentage of participants who were HBeAG positive with abnormal ALT at baseline, and who had HBV DNA < 400 copies/mL, ALT normalized, and seroconversion to HBeAg at Week 72 was summarized, using the M = F analysis with the DBEE algorithm.

  • Number of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    The number of participants with at least a 6% decrease from baseline in spine BMD at Week 48 was summarized by treatment and age group (grouped by baseline age for analysis).

  • Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    The mean (standard deviation [SD]) percent change from baseline in spine BMD at Week 48 was summarized.

  • Percent Change From Baseline in Spine BMD at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: Yes ]
    The mean (standard deviation [SD]) percent change from baseline in spine BMD at Week 72 was summarized.

  • Change in Z-score for Spine BMD at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    The change in mean (SD) Z-score for spine BMD at Week 48 was summarized. To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender.

  • Change in Z-score for Spine BMD at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: Yes ]
    The change in mean (SD) Z-score for spine BMD at Week 72 was summarized.

  • Percent Change From Baseline in Whole Body BMD at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    The mean (SD) percent change from baseline in whole body BMD at Week 48 was summarized.

  • Percent Change From Baseline in Whole Body BMD at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: Yes ]
    The mean (SD) percent change from baseline in whole body BMD at Week 72 was summarized.

  • Change in Z-score for Whole Body BMD at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    The change in mean (SD) Z-score for whole body BMD at Week 48 was summarized. To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for whole body spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender.

  • Change in Z-score for Whole Body BMD at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: Yes ]
    The change in mean (SD) Z-score for whole body BMD at Week 72 was summarized.

  • Number of Participants With Changes in Drug-resistant Mutations at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The number of participants with changes in drug-resistant mutations from baseline at Week 48 was summarized.

  • Number of Participants With Changes in Drug-resistant Mutations at Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
    The number of participants with changes in drug-resistant mutations from baseline at Week 72 was summarized.


Enrollment: 106
Study Start Date: September 2008
Estimated Study Completion Date: January 2016
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir disoproxil fumarate (TDF) Drug: Tenofovir disoproxil fumarate (TDF)
TDF administered as a 300-mg tablet, once daily (QD)
Other Name: Viread
Placebo Comparator: Placebo Drug: Placebo
Placebo to match TDF QD

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female, 12 through 17 years of age, inclusive (consent of parent/legal guardian required)
  • Documented chronic HBV infection
  • HBeAg positive or HBeAg negative
  • Weight > 35 kg
  • Able to swallow oral tablets
  • HBV DNA > 100,000 copies/mL (polymerase chain reaction [PCR] method)
  • ALT > 2 × upper limit of normal (ULN) at screening, OR any history of ALT > 2 × ULN over the past 24 months
  • Willing and able to provide written informed consent/assent (child and parent/legal guardian)
  • Negative serum pregnancy test (for postmenarchal females only)
  • Estimated glomerular filtration rate (creatinine clearance [using the Schwartz formula]) > 80 mL/min/1.73m^2
  • Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm^3; hemoglobin ≥ 10.0 g/dL)
  • No prior TDF therapy (participants may have received prior interferon or oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon therapy ≥ 6 months prior to screening; participants experienced on anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)

Exclusion Criteria

  • 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
  • Decompensated liver disease
  • Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
  • Receipt of anti-HBV nucleoside/nucleotide therapy within 16 weeks of the Screening Visit
  • Alpha fetoprotein > 50 ng/mL
  • Evidence of hepatocellular carcinoma (HCC)
  • Coinfection with HIV, HCV, or 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, osteochondroses, 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 nephrotoxic agents, competitors of renal excretion, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2 (IL-2), or other immunomodulating or investigational agents
  • 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 participants unsuitable for the study or unable to comply with dosing requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734162

Locations
United States, California
Children's Hospital & Research Center at Oakland
Oakland, California, United States, 94609
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Washington
Children's Hospital & Regional Medical Center, d/b/a Seattle Children's Research Institute
Seattle, Washington, United States, 98105
Bulgaria
Multiprofile Hospital for Active Treatment Sveti Georgi
Plovdiv, Bulgaria, 4002
Clinic of Gastroenterology, Specialized Hospital for Active Treatment of Pediatric Diseases, Sofia
Sofia, Bulgaria, 1606
France
Hopital Femmes Meres Enfants
Bron Cedex, France, 69677
Hôpital Claude Huriez
Lille Cedex, France, 59037
Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Akademii Medycznej w Bialymstoku
Białystok, Poland, 15-274
Wojewodzki Specjalistyczny Szpital im Bieganskiego
Bydgoszcz, Poland, 85-030
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
Bydgoszcz, Poland, 85-030
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Kraków, Poland, 31-202
Samodzielny Publiczny Szpital Kliniczny im. Karola Johschera
Poznan, Poland, 60-572
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem
Poznań, Poland, 61-734
Wojewodzki Szpital Zakazny
Warszawa, Poland, 01-201
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wrocław, Poland, 50-368
Romania
Institute for Infectious Diseases
Bucharest, Romania, 21105
Fundeni Clinical Institute
Bucharest, Romania, 022328
Cluj Childrens Emergency Hospital
Napaco, Romania, 400217
Spain
Hosp Univ y Politecnico La Fe de Valencia
Madrid, Spain, 28046
Hospital Universitario De Getafe
Madrid, Spain, 46009
Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey, 35100
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Benedetta Massetto, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00734162     History of Changes
Other Study ID Numbers: GS-US-174-0115
Study First Received: August 13, 2008
Results First Received: October 8, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
tenofovir
adolescents
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 16, 2014