BridgeMD
N/A
EU CTIS ID: 2024-517526-26-00
What this study is testing
To evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.
- Therapeutic confirmatory (Phase III)
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
- Male or Female, 2 to < 12 years of age
- No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants 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)
- Weight ≥ 10 kg
- Chronic HBV infection ≥ 6 months
- Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
- HBV Viral Load ≥ 100,000 copies/mL
You likely can't join if
- Pregnant or lactating
- Long term non-steroidal, anti-inflammatory drug therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply
- 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
See the full eligibility criteria
- Male or Female, 2 to < 12 years of age
- No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants 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)
- Weight ≥ 10 kg
- Chronic HBV infection ≥ 6 months
- Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
- HBV Viral Load ≥ 100,000 copies/mL
- Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
- Creatinine Clearance ≥ 80 mL/min/1.73m^2
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10 g/dL
- Negative pregnancy test at screening
- Pregnant or lactating
- Long term non-steroidal, anti-inflammatory drug therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply
- 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 human immunodeficiency virus (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
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Korea, Republic of
- United States
- India
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 Taiwan; Korea, Republic of; United States; India. 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.