Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

Gilead Sciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir DF; Drug: TDF Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651403

2024-517526-26 (Other Identifier)

2012-000586-20 (EudraCT Number)

GS-US-174-0144

Details and patient eligibility

About

The primary objective of this study is 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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or Female, 2 to < 12 years of age
• 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
• 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)

Key Exclusion Criteria:

• Pregnant or lactating
• 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
• Long term non-steroidal, anti-inflammatory drug therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 4 patient groups, including a placebo group

Tenofovir DF (Blinded Randomized Treatment)

Experimental group

Description:

Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).

Treatment:

Drug: Tenofovir DF

Placebo to match TDF (Blinded Randomized Treatment)

Placebo Comparator group

Description:

Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).

Treatment:

Drug: TDF Placebo

Tenofovir DF (Open-label Treatment)

Experimental group

Description:

Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Treatment:

Drug: Tenofovir DF

Tenofovir DF (Open-label Extension Phase)

Experimental group

Description:

Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight.

Treatment:

Drug: Tenofovir DF