Clinical trial

A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection

Name

GS-US-174-0144

Description

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.

Trial arms

Trial start

2012-12-06

Estimated PCD

2017-08-07

Trial end

2027-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Tenofovir DF

* Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.

Arms:

Tenofovir DF (Blinded Randomized Treatment), Tenofovir DF (Open-label Extension Phase), Tenofovir DF (Open-label Treatment)

Other names:

Viread®

TDF Placebo

* Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.

Arms:

Placebo to match TDF (Blinded Randomized Treatment)

Size

Primary endpoint

Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)

Week 48

Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)

Week 48

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2023-12-13

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product