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Trial record 72 of 362 for:    hepatitis b | Open Studies

Tenofovir Alafenamide (TAF) in Adolescents With Chronic Hepatitis B Virus Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02932150
First received: September 16, 2016
Last updated: April 26, 2017
Last verified: April 2017
  Purpose

The primary objectives of this study are as follows:

Part A: To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (TAF) and confirm the dose of TAF 25 mg tablet given once daily in treatment-naive and treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB)

Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents with CHB.


Condition Intervention Phase
Chronic Hepatitis B
Drug: TAF
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Adolescents With Chronic Hepatitis B Virus Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events at Week 24 [ Time Frame: Week 24 ]
  • Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • Percentage of participants experiencing graded laboratory abnormalities [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Development as measured by Tanner Stage Assessment [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Percentage change from baseline in bone mineral density (BMD) of whole body (minus head) by dual imaging x-ray absorptiometry (DXA) [ Time Frame: Baseline; Weeks 24, 48, 96, and 240 ]
  • Percentage change from baseline in BMD of lumbar spine by DXA [ Time Frame: Baseline; Weeks 24, 48, 96, and 240 ]
  • Change from baseline in serum creatinine [ Time Frame: Baseline; Weeks 24, 48, 96, and 240 ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula [ Time Frame: Baseline; Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240 [ Time Frame: Weeks 48, 96, and 240 ]
  • Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240 [ Time Frame: Weeks 24, 48, 96 and 240 ]
  • Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240 [ Time Frame: Baseline; Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with hepatitis B e antigen (HBeAg) loss at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with HBeAg seroconversion to anti-HBe at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only) [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Composite endpoint of percentage of participants with HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only) [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with hepatitis B surface antigen (HBsAg) loss at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Percentage of participants with HBsAg seroconversion to anti-HBs at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Incidence of resistance mutations at Weeks 24, 48, 96, and 240 [ Time Frame: Weeks 24, 48, 96, and 240 ]
  • Acceptability of study drug [ Time Frame: Baseline; Weeks 4, 24, and 36 ]
    To assess acceptability of study drug, the investigator will ask participants on a scale of 1-7 how much they like the taste of the medication (1 = dislike very much to 7 = like very much).

  • Palatability of study drug [ Time Frame: Baseline; Weeks 4, 24, and 36 ]
    To assess palatability of study drug, the investigator will ask participants on a scale of 0-3 how easy it was to swallow the pill (0 = poor to 3 = excellent).


Estimated Enrollment: 75
Actual Study Start Date: November 2016
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAF
TAF for 24 weeks during Part A or B
Drug: TAF
25 mg tablet administered orally once daily
Placebo Comparator: Placebo
Placebo for 24 weeks during Part A or B
Drug: Placebo
Tablet administered orally once daily
Experimental: Open-Label TAF
Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.
Drug: TAF
25 mg tablet administered orally once daily

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria:

  • Males and non-pregnant, non-lactating females
  • Weight at Screening: ≥ 35 kg (77 lbs)
  • Able to swallow oral tablets
  • Willing and able to provide written informed consent/assent (child and parent/legal guardian)
  • Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
  • Treatment-naive or treatment-experienced will be eligible for enrollment.
  • Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartz formula)
  • Normal ECG

Key Exclusion criteria:

  • Females who are breastfeeding
  • Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
  • Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
  • Evidence of hepatocellular carcinoma
  • Any history of, or current evidence of, clinical hepatic decompensation
  • Abnormal hematological and biochemical parameters
  • Received solid organ or bone marrow transplant
  • Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
  • Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
  • Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02932150

Contacts
Contact: Gilead Study Team GS-US-320-1092@gilead.com

Locations
United States, California
Recruiting
San Francisco, California, United States, 94158
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21287
United States, Texas
Recruiting
Fort Worth, Texas, United States, 76104
Recruiting
San Antonio, Texas, United States, 78215
United States, Washington
Recruiting
Seattle, Washington, United States, 98105
United States, West Virginia
Recruiting
Morgantown, West Virginia, United States, 26506
Belgium
Recruiting
Brussels, Belgium, 1200
Korea, Republic of
Recruiting
Daegu, Korea, Republic of, 41944
Recruiting
Seoul, Korea, Republic of, 03080
Recruiting
Seoul, Korea, Republic of, 03722
Recruiting
Seoul, Korea, Republic of, 06351
Russian Federation
Recruiting
Kazan, Tatarstan, Russian Federation, 420110
Recruiting
Moscow, Russian Federation, 111123
Recruiting
Moscow, Russian Federation, 115446
Recruiting
Tolyatti, Russian Federation, 445009
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02932150     History of Changes
Other Study ID Numbers: GS-US-320-1092
2016-000785-37 ( EudraCT Number )
Study First Received: September 16, 2016
Last Updated: April 26, 2017

Keywords provided by Gilead Sciences:
CHB
HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System 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

ClinicalTrials.gov processed this record on May 25, 2017