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Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
EU CTIS ID: 2023-506143-42-00
What this study is testing
Cohort 1 (adolescents 12 to < 18 years, ≥ 35 kg): -To evaluate the safety, tolerability, and antiviral activity (hepatitis B virus [HBV] DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo at Week 24 in adolescent subjects with chronic hepatitis B (CHB) Cohort 2 (children 2 to < 12 years of age): Part A: - To evaluate the steady-state pharmacokinetics (PK) of TAF and TAF-metabolite, tenofovir (TFV), and confirm the dose of TAF given once daily in children with CHB Part B: - To evaluate the safety, efficacy, and tolerability of TAF given once daily at Week 24 in children with CHB - To evaluate the antiviral activity (HBV DNA < 20 IU/mL) of TAF given once daily versus placebo at Week 24 in children with CHB
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ages Eligible for Study: 2 Years to 17 Years (Child)
- Note: Other protocol defined Inclusion criteria may apply.
- Males and non-pregnant, non-lactating females
- Weight at screening as follows: Cohort 1 = ≥ 35 kg (≥ 77 lbs) Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs) Cohort 2 Group 2 = ≥ 14 kg to < 25 kg (≥ 30 lbs to <55 lbs) Cohort 2 Group 3 = ≥ 10 kg to < 14 kg (≥ 22 lbs to < 30 lbs) or 14 kg to < 25 kg (≥ 30 lbs to < 55 lbs)
- Willing and able to provide written informed consent/assent (child and parent/legal guardian)
- Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
You likely can't join if
- Females who are pregnant or breastfeeding
- 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 Exclusion criteria may apply.'
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
See the full eligibility criteria
- Ages Eligible for Study: 2 Years to 17 Years (Child)
- Note: Other protocol defined Inclusion criteria may apply.
- Males and non-pregnant, non-lactating females
- Weight at screening as follows: Cohort 1 = ≥ 35 kg (≥ 77 lbs) Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs) Cohort 2 Group 2 = ≥ 14 kg to < 25 kg (≥ 30 lbs to <55 lbs) Cohort 2 Group 3 = ≥ 10 kg to < 14 kg (≥ 22 lbs to < 30 lbs) or 14 kg to < 25 kg (≥ 30 lbs to < 55 lbs)
- Willing and able to provide written informed consent/assent (child and parent/legal guardian)
- Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
- HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following: Screening HBV DNA ≥ 2 × 10^4 IU/mL Screening serum ALT > 45 U/L (> 1.5 × ULN: 30 U/L) and ≤ 10 × ULN (by central laboratory range)
- 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
- Females who are pregnant or breastfeeding
- 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 Exclusion criteria may apply.'
- 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
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
- Received solid organ or bone marrow transplant
- Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- New Zealand
- Hong Kong
- Taiwan
- India
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; New Zealand; Hong Kong; Taiwan; India; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.