A study to understand the safety and effectiveness of a new drug called TAF for the treatment of long term hepatitis B infection in adolescents and childre

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-000785-37-BE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-25
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) Males and non-pregnant, non-lactating females
2) Age at Screening: 2 to < 18 years old
3) Weight at Screening as follows:
-Cohort 1: 12 years to < 18 years and = 35 kg (=77 lbs)
-Cohort 2 (Group 1): 6 years to < 12 years and = 25 kg (=55 lbs)
-Cohort 2 (Group 2): 6 years to < 12 years and =17 kg to < 25 kg (=37 lbs to <55 lbs)
-Cohort 2 (Group 3^): 2 years to < 6 years and <17 kg^^ (<37 lbs)^^
^Subjects unable to swallow a tablet
^^Body weight cutoff at Screening to be determined

4) Willing and able to provide written informed consent/assent (child and parent/legal guardian)
5) Documented evidence of CHB (e.g. HBsAg-positive for = 6 months)
6) HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
a) Screening HBV DNA = 2 × 10000 IU/mL
b) Screening serum ALT > 45 U/L (>1.5 × ULN; 30 U/L) and = 10 × ULN (by central laboratory range)
7) Treatment-naïve (defined as < 12 weeks of oral antiviral (OAV) treatment with any oral nucleos(t)ide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serum ALT criteria] and with = 12 weeks of previous treatment with any nucleos(t)ide analogue) will be eligible for enrollment. All treatment-experienced subjects must have discontinued oral nucleos(t)ide therapy = 16 weeks prior to screening to avoid ALT flare if randomized to the placebo arm.
8) Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 24 weeks prior to the Baseline visit
9) Estimated creatinine clearance (CLCr) = 80 mL/min/1.73m^2 (using the Schwartz formula; = k × L/sCr) [(k is a proportionality constant: for adolescent females = 12 years old, k = 0.55, and for adolescent males = 12 years, k = 0.70); L is height in centimeters (cm); and sCr is serum creatinine (mg/dL)]
10) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
11) Must be willing and able to comply with all study requirements
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pregnant females, females who are breastfeeding or who believe they may wish to become pregnant during the course of the study
2) Males and females of reproductive potential who are unwilling to use an effective”, protocol-specified method(s) of contraception during the study. For a list of protocol-specified contraceptive methods, refer to Appendix 5.
3) Coinfection with HCV, HIV, or HDV
4) Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein [AFP] is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
5) Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
6) Abnormal hematological and biochemical parameters
7) Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
8) Received solid organ or bone marrow transplant
9) Currently receiving therapy with immunomodulators (e.g. corticosteroids), or immunosuppressants
10) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
11) Malignancy within the 5 years prior to screening. Subjects under evaluation for possible malignancy are not eligible.
12) Known hypersensitivity to study drugs, metabolites, or formulation excipients.
13) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
14) Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 28 days prior to the Baseline visit.
15) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified