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

NCT01651403 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-174-01442012-000586-202024-517526-26
• Study Type: interventional
• Target: 90
• Locations: 5 countries
• Sites: 21

Brief Summary

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (27)

• Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48

  Week 48

• Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range

  Week 48

• Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range

  Week 192

• Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range

  Week 48

• Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range

  Week 192

Study Arms (4)

Tenofovir DF (Blinded Randomized Treatment)

EXPERIMENTAL

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

Drug: Tenofovir DF

Placebo to match TDF (Blinded Randomized Treatment)

PLACEBO COMPARATOR

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

Drug: TDF Placebo

Tenofovir DF (Open-label Treatment)

EXPERIMENTAL

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).

Drug: Tenofovir DF

Tenofovir DF (Open-label Extension Phase)

EXPERIMENTAL

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.

Drug: Tenofovir DF

Interventions

TDF Placebo DRUG

* 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.

Placebo to match TDF (Blinded Randomized Treatment)

Tenofovir DF DRUG

* 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.

Also known as: Viread®

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

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (21)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Nirmal Hospital Private Limited

Surat, Gujarat, 395 002, India

Location

Medanta -The Medicity

Gurgaon, Haryana, 122 001, India

Location

Colors Children Hospital

Nagpur, Maharashtra, 440012, India

Location

SMS Medical College and Hospital

Jaipur, Rajasthan, 302004, India

Location

M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk

Lucknow, Uttar Pradesh, 226003, India

Location

St. John Hospital & Medical Center

Bangalore, 560034, India

Location

Grigore Alexandrescu Emergency Clinical Hospital for Children

Bucharest, 011743, Romania

Location

Fundeni Clinical Institute - Constantinesco

Bucharest, 022328, Romania

Location

Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology

Craiova, 200515, Romania

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Kyungpook National University

Daegu, 41944, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Severance Children's Hospital

Seoul, 120-752, South Korea

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• (Oral Presentation) Mei-Hwei Chang, Jae Hong Park, Jorge A. Bezerra, Daniela Pacura, Sandeep Nijhawan, Byung-Ho Choe, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate (TDF) in Children with Chronic Hepatitis B (CHB). Hepatology, 2018; 68 (Suppl 1): 49A.

  RESULT

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: December 6, 2012
• Primary Completion: August 7, 2017
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 30, 2026
• Results First Posted: September 19, 2018

Record last verified: 2026-01

Locations

KR (5); US (5); RO (3); TW (2); IN (6)