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Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B Infection

Intervention: Tenofovir DF (Drug); Placebo to match TDF (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
John Flaherty, PharmD, Study Director, Affiliation: Gilead Sciences

Overall contact:
Gilead Study Team, Email: 174-0144@gilead.com

Summary

This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B infection. While studies have shown significant virologic response in adults and adolescents, the effect in children is not well established. This study will provide valuable data that can help establish the efficacy and safety profiles of TDF in children. The study will consist of 72 weeks of blinded randomized treatment, after which participants will switch to open-label TDF treatment for an additional 120 weeks.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Proportion of participants with serum HBV DNA < 400 copies/mL at week 72

Secondary outcome:

Proportion of participants with hepatitis B e antigen (HBeAg) seroconversion at Week 72

Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine

Percent change from baseline in bone mineral density of lumbar spine

Proportion of participants with normal ALT and normalization of ALT

Composite endpoint of proportion of participants with HBV DNA < 400 copies/mL and normal ALT

Genotypic changes from baseline within the HBV polymerase for patients who were viremic (HBV DNA > or equal 400 copies/mL) with confirmed virologic breakthrough

Proportion of participants with HBV DNA < 169 copies/mL

Proportion of participants with HBsAg loss and seroconversion

Eligibility

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or Female, 2 to < 12 years of age

- Weight ≥ 10kg

- Chronic HBV infection ≥ 6 months

- HBeAg-positive or HBeAg-negative

- HBV Viral Load ≥ 100,000 copies/mL

- Alanin aminotransferase (ALT) ≥ 1. 5 x the upper limit of the normal range (ULN) at

screening

- Creatinine Clearance ≥ 80 mL/min

- Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10g/dL

- Negative pregnancy test at screening

- No prior tenofovir DF therapy (subjects may have received prior interferon‑alfa

and/or other oral anti‑HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; subjects 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) 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 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

Locations and Contacts

Gilead Study Team, Email: 174-0144@gilead.com

Dr. Georgi Stranski Multiprofile Hospital for Active Treatment, Pleven 5800, Bulgaria; Withdrawn

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plodiv 4002, Bulgaria; Recruiting

Multiprofile Hospital for Active Treatment "Tokuda Hospital", Sofia 1407, Bulgaria; Recruiting

Nirmal Hospital Private Limited, Gujarat 395 002, India; Recruiting

Indraprastha Apollo Hospitals, New Delhi 110076, India; Recruiting

SMS Medical College and Hospital, Rajasthan 302004, India; Recruiting

Kyungpook National University, Daegu 700-721, Korea, Republic of; Recruiting

Gachon University Gil Hospital, Department of Pediatrics, Incheon 405-760, Korea, Republic of; Withdrawn

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting

Severance Children's Hospital, Seoul 120-752, Korea, Republic of; Recruiting

Pusan National University Yangsan Hospital, Yangsan-si 626 770, Korea, Republic of; Recruiting

ID Clinic, Myslowice 41-400, Poland; Withdrawn

Fundeni Clinical Institute - Constantinesco, Bucharest 022328, Romania; Recruiting

Grigore Alexandrescu Emergency Clinical Hospital for Children, Bucharest 011743, Romania; Active, not recruiting

National Institute of Infectious Diseases, Bucharest 021105, Romania; Withdrawn

Clinical Infectious Diseases Hospital of Constanta, Constanta 900708, Romania; Withdrawn

"Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisology, Craiova 200515, Romania; Recruiting

National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting

Taipei Veterans General Hospital, Taipei 11217, Taiwan; Recruiting

Gandhi Hospital and Medical College, Secunderabad, Andhra Pradesh 500-033, India; Recruiting

King George Hospital, Visakhapatnam, Andhra Prasad 530 002, India; Recruiting

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States; Recruiting

University of California, San Francisco, San Francisco, California 94143, United States; Recruiting

University of Colorado School of Medicine, Aurora, Colorado 80045, United States; Recruiting

Medanta -The Medicity, Gurgaon, Haryana 122 001, India; Recruiting

Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India; Recruiting

Colors Children Hospital, Nagpur, Maharashtra 440012, India; Recruiting

New York School of Medicine, New York, New York 10016, United States; Recruiting

Sparsh Hospital, Bhubaneswar, Odhisa Andaman and Nicobar Islands 751007, India; Recruiting

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting

Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting

M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk, Lucknow, Uttar Pradesh 226003, India; Recruiting

Additional Information

Starting date: December 2012
Last updated: August 18, 2015

Page last updated: August 23, 2015

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