Back to resultsStudy to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Primary Purpose
Chronic Hepatitis B
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tenofovir DF
TDF Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
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
Sites / Locations
- Phoenix Children's Hospital
- University of California, San Francisco
- Children's Hospital Colorado
- Cincinnati Children's Hospital Medical Center
- Texas Children's Hospital
- Nirmal Hospital Private Limited
- Medanta -The Medicity
- Colors Children Hospital
- SMS Medical College and Hospital
- M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
- St. John Hospital & Medical Center
- Pusan National University Yangsan Hospital
- Kyungpook National University
- Asan Medical Center
- Samsung Medical Center
- Severance Children's Hospital
- Grigore Alexandrescu Emergency Clinical Hospital for Children
- Fundeni Clinical Institute - Constantinesco
- Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
- National Taiwan University Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Tenofovir DF (Blinded Randomized Treatment)
Placebo to match TDF (Blinded Randomized Treatment)
Tenofovir DF (Open-label Treatment)
Tenofovir DF (Open-label Extension Phase)
Arm Description
Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
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).
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
Secondary Outcome Measures
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.
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
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
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.
Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
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.
Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
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.
Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
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.
Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
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.
Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
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.
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
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.
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
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.
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
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.
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
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.
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
Percentage of Participants With HBsAg Loss at Week 48
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Percentage of Participants With HBsAg Loss at Week 192
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Percentage of Participants With HBsAg Seroconversion at Week 48
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Percentage of Participants With HBsAg Seroconversion at Week 192
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
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
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
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
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
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
Percent Change From Baseline in BMD of Spine at Week 48
Percent Change From Baseline in BMD of Spine at Week 192
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651403
Brief Title
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2012 (Actual)
Primary Completion Date
August 7, 2017 (Actual)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir DF (Blinded Randomized Treatment)
Arm Type
Experimental
Arm Description
Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
Arm Title
Placebo to match TDF (Blinded Randomized Treatment)
Arm Type
Placebo Comparator
Arm Description
Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
Arm Title
Tenofovir DF (Open-label Treatment)
Arm Type
Experimental
Arm Description
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).
Arm Title
Tenofovir DF (Open-label Extension Phase)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenofovir DF
Other Intervention Name(s)
Viread®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TDF Placebo
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Time Frame
Week 48
Title
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
Description
HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.
Time Frame
Week 48
Title
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
Description
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Time Frame
Week 48
Title
Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
Description
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range.
Time Frame
Week 192
Title
Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
Description
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.
Time Frame
Week 48
Title
Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
Description
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.
Time Frame
Week 192
Title
Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
Description
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.
Time Frame
Week 48
Title
Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
Description
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.
Time Frame
Week 192
Title
Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
Description
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.
Time Frame
Week 48
Title
Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
Description
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.
Time Frame
Week 192
Title
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
Description
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.
Time Frame
Week 48
Title
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
Description
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.
Time Frame
Week 192
Title
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
Description
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.
Time Frame
Week 48
Title
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
Description
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.
Time Frame
Week 192
Title
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
Time Frame
Week 48
Title
Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
Time Frame
Week 192
Title
Percentage of Participants With HBsAg Loss at Week 48
Description
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Time Frame
Week 48
Title
Percentage of Participants With HBsAg Loss at Week 192
Description
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.
Time Frame
Week 192
Title
Percentage of Participants With HBsAg Seroconversion at Week 48
Description
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Time Frame
Week 48
Title
Percentage of Participants With HBsAg Seroconversion at Week 192
Description
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.
Time Frame
Week 192
Title
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
Title
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
Title
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
Title
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
Title
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Time Frame
Baseline; Week 48
Title
Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
Time Frame
Baseline; Week 192
Title
Percent Change From Baseline in BMD of Spine at Week 48
Time Frame
Baseline; Week 48
Title
Percent Change From Baseline in BMD of Spine at Week 192
Time Frame
Baseline; Week 192
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Nirmal Hospital Private Limited
City
Surat
State/Province
Gujrat
ZIP/Postal Code
395 002
Country
India
Facility Name
Medanta -The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122 001
Country
India
Facility Name
Colors Children Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
SMS Medical College and Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
St. John Hospital & Medical Center
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongnam
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Kyungpook National University
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Severance Children's Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Grigore Alexandrescu Emergency Clinical Hospital for Children
City
Bucharest
ZIP/Postal Code
011743
Country
Romania
Facility Name
Fundeni Clinical Institute - Constantinesco
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Citations:
Citation
(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.
Results Reference
result
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-174-0144
Description
Gilead Clinical Trials Website
Learn more about this trial
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
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