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Summary

for people ages 12–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Chronic Hepatitis B CHB HBV Tenofovir

Eligibility

For people ages 12–17

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/1.73m2 (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.

Locations

  • San Francisco, California, 94158, United States
  • Seattle, Washington, 98105, United States
  • Fort Worth, Texas, 76104, United States
  • Omaha, Nebraska, 68198, United States
  • San Antonio, Texas, 78215, United States
  • Houston, Texas, 77030, United States
  • Indianapolis, Indiana, 46202, United States
  • Morgantown, West Virginia, 26506, United States
  • Baltimore, Maryland, 21287, United States
  • Kazan, Tatarstan, 420110, Russian Federation
  • Krasnoyarsk, 660074, Russian Federation
  • Moscow, 111123, Russian Federation
  • Moscow, 115446, Russian Federation
  • Moscow, 119991, Russian Federation
  • Saint Petersburg, 197022, Russian Federation
  • Saint Petersburg, 197101, Russian Federation
  • Tolyatti, 445009, Russian Federation
  • Brussels, 1200, Belgium
  • Daegu, 41944, Korea, Republic of
  • Seoul, 03080, Korea, Republic of
  • Seoul, 03722, Korea, Republic of
  • Seoul, 05505, Korea, Republic of
  • Seoul, 06351, Korea, Republic of
  • Kaohsiung, 807, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Hong Kong, Hong Kong

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02932150
Phase
Phase 2
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
September 1, 2017
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