We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01651403
Recruitment Status : Active, not recruiting
First Posted : July 27, 2012
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Infection Drug: Tenofovir DF Drug: TDF Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Pediatric Patients With Chronic Hepatitis B Infection
Actual Study Start Date : December 6, 2012
Primary Completion Date : August 7, 2017
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tenofovir DF (Blinded Randomized Treatment)
Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 48 weeks.
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®
Placebo Comparator: Placebo to match TDF (Blinded Randomized Treatment)
Participants will receive TDF placebo for 48 weeks.
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 (Open-label Treatment)
Following 48 weeks of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 144 weeks.
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®
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.
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®



Primary Outcome Measures :
  1. Proportion of Participants with Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Proportion of Participants with Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 [ Time Frame: Week 48 ]
  2. Proportion of Participants with Normal ALT and Normalization of ALT [ Time Frame: Week 48 ]
  3. Composite Endpoint of Proportion of Participants with HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT [ Time Frame: Week 48 ]
  4. Proportion of Participants with HBV DNA < 169 Copies/mL (29 IU/mL) [ Time Frame: Week 48 ]
  5. Proportions of Participants with HBsAg Loss and Seroconversion [ Time Frame: Week 48 ]
  6. 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 ]
  7. Cumulative Incidence of at least 4% Decrease From Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Baseline; Week 48 ]
  8. Percent Change from Baseline in Bone Mineral Density of Lumbar Spine [ Time Frame: Baseline; Week 48 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651403


Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Bulgaria
Multiprofile Hospital for Active Treatment Sveti Georgi
Plovdiv, Bulgaria, 4002
India
Nirmal Hospital Private Limited
Surat, Gujrat, India, 395 002
Medanta -The Medicity
Gurgaon, Haryana, India, 122 001
Colors Children Hospital
Nagpur, Maharashtra, India, 440012
SMS Medical College and Hospital
Jaipur, Rajasthan, India, 302004
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
Lucknow, Uttar Pradesh, India, 226003
St. John Hospital & Medical Center
Bangalore, India, 560034
Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongnam, Korea, Republic of, 626 770
Kyungpook National University
Daegu, Korea, Republic of, 700-721
Severance Children's Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Romania
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, Romania, 011743
Fundeni Clinical Institute - Constantinesco
Bucharest, Romania, 022328
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
Craiova, Romania, 200515
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01651403     History of Changes
Other Study ID Numbers: GS-US-174-0144
2012-000586-20 ( EudraCT Number )
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Gilead Sciences:
Hepatitis
Hepatitis B
HBV

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents