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Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01651403
First received: July 25, 2012
Last updated: December 23, 2016
Last verified: December 2016

July 25, 2012
December 23, 2016
December 2012
August 2017   (Final data collection date for primary outcome measure)
Proportion of Participants with Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 [ Time Frame: Week 48 ]
Proportion of patients with serum HBV DNA < 400 copies/mL at week 72 [ Time Frame: Week 72 ]
Complete list of historical versions of study NCT01651403 on ClinicalTrials.gov Archive Site
  • Proportion of Participants with Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 [ Time Frame: Week 48 ]
  • Proportion of Participants with Normal ALT and Normalization of ALT [ Time Frame: Week 48 ]
  • Composite Endpoint of Proportion of Participants with HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT [ Time Frame: Week 48 ]
  • Proportion of Participants with HBV DNA < 169 Copies/mL (29 IU/mL) [ Time Frame: Week 48 ]
  • Proportions of Participants with HBsAg Loss and Seroconversion [ Time Frame: Week 48 ]
  • Sequence Changes From Baseline Within the HBV Polymerase for Participants who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) at Weeks 48, 96, 144, 192 or Early Discontinuation; Including Participants with Confirmed Virologic Breakthrough [ Time Frame: Baseline; Weeks 48, 96, 144, 192 or Early Discontinuation ]
  • Cumulative Incidence of at least 4% Decrease From Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Baseline; Week 48 ]
  • Percent Change from Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Baseline; Week 48 ]
  • Proportion of patients with HBeAg seroconversion at week 72 [ Time Frame: Week 72 ]
  • Cumulative Incidence of at least 4% Decrease From Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Week 72 ]
  • Percent Change from Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Week 72 ]
  • Safety and Tolerability of Therapy [ Time Frame: Up to Week 192 ]
    Safety and tolerability is measured by the frequency of laboratory abnormalities reported as adverse events.
  • Biochemical and serological responses [ Time Frame: Week 72 ]
    Biochemical and serological responses as measured by normal/normalization of ALT, proportion of subjects with HBV DNA < 400 copies/mL and normal ALT, proportion of subjects with HBV DNA < 169 copies/mL, proportion of subjects with HBsAg loss and seroconversion
  • Viral Resistance [ Time Frame: Weeks 72, 144, 192 or Early Discontinuation ]
    Genotypic changes from baseline within the HBV polymerase for patients who were viremic (HBV DNA > or equal 400 copies/mL) with confirmed virologic breakthrough
Not Provided
Not Provided
 
Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection
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
This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B infection. While studies have shown significant virologic response in adults and adolescents, the effect in children is not well established. This study will provide valuable data that can help establish the efficacy and safety profiles of TDF in children. The study will consist of 48 weeks of blinded randomized treatment, after which participants will switch to open-label TDF treatment for an additional 144 weeks.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis B Infection
  • Drug: Tenofovir DF
    • 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 300mg.
    Other Name: Viread®
  • Drug: TDF Placebo
    • 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.
  • Experimental: Tenofovir DF (Blinded Randomized Treatment)
    Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 48 weeks.
    Intervention: Drug: Tenofovir DF
  • Placebo Comparator: Placebo to match TDF (Blinded Randomized Treatment)
    Participants will receive TDF placebo for 48 weeks.
    Intervention: Drug: TDF Placebo
  • Experimental: Tenofovir DF (Open-label Treatment)
    Following 48 weeks of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 144 weeks.
    Intervention: Drug: Tenofovir DF
  • Experimental: Tenofovir DF (Open-label Extension Phase)
    Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in patients of their age and weight.
    Intervention: Drug: Tenofovir DF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 2025
August 2017   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

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

Sexes Eligible for Study: All
2 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Korea, Republic of,   Romania,   Taiwan
Bulgaria,   Poland
 
NCT01651403
GS-US-174-0144
2012-000586-20 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP