Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
NCT ID: NCT01651403
Last Updated: 2025-01-08
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2012-12-06
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tenofovir DF (Blinded Randomized Treatment)
Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
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 300 mg.
Placebo to match TDF (Blinded Randomized Treatment)
Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
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.
Tenofovir DF (Open-label Treatment)
Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
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 300 mg.
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 participants of their age and weight.
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 300 mg.
Interventions
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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 300 mg.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
2 Years
11 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Nirmal Hospital Private Limited
Surat, Gujarat, India
Medanta -The Medicity
Gurgaon, Haryana, India
Colors Children Hospital
Nagpur, Maharashtra, India
SMS Medical College and Hospital
Jaipur, Rajasthan, India
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
Lucknow, Uttar Pradesh, India
St. John Hospital & Medical Center
Bangalore, , India
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, , Romania
Fundeni Clinical Institute - Constantinesco
Bucharest, , Romania
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
Craiova, , Romania
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Kyungpook National University
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Children's Hospital
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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(Oral Presentation) Mei-Hwei Chang, Jae Hong Park, Jorge A. Bezerra, Daniela Pacura, Sandeep Nijhawan, Byung-Ho Choe, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate (TDF) in Children with Chronic Hepatitis B (CHB). Hepatology, 2018; 68 (Suppl 1): 49A.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Statistical Analysis Plan: Week 48 Analysis
Document Type: Statistical Analysis Plan: Week 192 Analysis
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2012-000586-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-517526-26
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-174-0144
Identifier Type: -
Identifier Source: org_study_id
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