We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified December 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02932150
First Posted: October 13, 2016
Last Update Posted: December 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
The primary objective of this study is evaluate the safety, tolerability and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescent adolescents (aged 12 to < 18 years) with chronic hepatitis B (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: Double (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).

  • Pharmacokinetic (PK) Parameter: AUCtau of TAF and tenofovir (TFV) for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  • PK Parameter: AUClast of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  • PK Parameter: Ctau of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  • PK Parameter: Cmax of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Cmax is defined as the maximum observed concentration of drug.

  • PK Parameter: Clast of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Clast is defined as the last observable concentration of drug.

  • PK Parameter: Tmax of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Tmax is defined as the time of Cmax (the maximum concentration of drug).

  • PK Parameter: Tlast of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Tlast is defined as the time (observed time point) of Clast.

  • PK Parameter: λz of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.

  • PK Parameter: CL/F of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    CL/F is defined as the apparent oral clearance following administration of the drug.

  • PK Parameter: Vz/F of TAF and TFV for participants who participate in the optional intensive PK substudy [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    Vz/F is defined as the apparent volume of distribution of the drug.

  • PK Parameter: t1/2 of TAF and TFV for participants who participate in the optional intensive PK substudy (where possible) [ Time Frame: Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 ]
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.


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
Drug: TAF
25 mg tablet administered orally once daily
Placebo Comparator: Placebo
Placebo for 24 weeks
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

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:   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 whole
  • 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 (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
  • 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
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): NCT02932150


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

  Show 36 Study Locations
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 )
First Submitted: September 16, 2016
First Posted: October 13, 2016
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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