Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01651403

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nirmal Hospital Private Limited, Surat, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or Female, 2 to < 12 years of age
  • Weight ≥ 10 kg
  • Chronic HBV infection ≥ 6 months
  • Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
  • HBV Viral Load ≥ 100,000 copies/mL
  • Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
  • Creatinine Clearance ≥ 80 mL/min/1.73m^2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10 g/dL
  • Negative pregnancy test at screening
  • No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)

Key Exclusion Criteria:

  • Pregnant or lactating
  • Decompensated liver disease
  • Received interferon therapy within 6 months of screening
  • Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
  • Alpha-fetoprotein levels > 50 ng/mL
  • Evidence of hepatocellular carcinoma (HCC)
  • Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
  • Chronic liver disease not due to HBV
  • History of significant renal, cardiovascular, pulmonary, neurological or bone disease
  • Long term non-steroidal, anti-inflammatory drug therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Tenofovir DF

Drug
  • Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight).
  • Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.

Other names: Viread®

TDF placebo

Drug
  • Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily.
  • Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.

Primary outcomes

  1. Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)

    Time frame: Week 48

  2. Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)

    Time frame: Week 48

Secondary outcomes

  1. Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48

    Time frame: Week 48

    HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.

  2. Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range

    Time frame: Week 48

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.

  3. Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range

    Time frame: Week 192

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.

  4. Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range

    Time frame: Week 48

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.

  5. Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range

    Time frame: Week 192

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range.

  6. Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range

    Time frame: Week 48

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  7. Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range

    Time frame: Week 192

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  8. Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range

    Time frame: Week 48

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  9. Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range

    Time frame: Week 192

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  10. Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48

    Time frame: Week 48

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  11. Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192

    Time frame: Week 192

    Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  12. Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48

    Time frame: Week 48

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  13. Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192

    Time frame: Week 192

    Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.

  14. Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48

    Time frame: Week 48

  15. Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192

    Time frame: Week 192

  16. Percentage of Participants With HBsAg Loss at Week 48

    Time frame: Week 48

    HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.

  17. Percentage of Participants With HBsAg Loss at Week 192

    Time frame: Week 192

    HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.

  18. Percentage of Participants With HBsAg Seroconversion at Week 48

    Time frame: Week 48

    HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.

  19. Percentage of Participants With HBsAg Seroconversion at Week 192

    Time frame: Week 192

    HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.

  20. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48

    Time frame: Baseline; Week 48

  21. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96

    Time frame: Baseline; Week 96

  22. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144

    Time frame: Baseline; Week 144

  23. Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192

    Time frame: Baseline; Week 192

  24. Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48

    Time frame: Baseline; Week 48

  25. Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192

    Time frame: Baseline; Week 192

  26. Percent Change From Baseline in BMD of Spine at Week 48

    Time frame: Baseline; Week 48

  27. Percent Change From Baseline in BMD of Spine at Week 192

    Time frame: Baseline; Week 192

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection

Important dates

Study start
2012
Primary completion
2017
Study completion
2027
First posted
Jul 27, 2012
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.