Evaluating the movement of drug within the body, safety and Antiviral Efficacy of Tenofovir Alafenamide in Paediatric patients with chronic Hepatitis B infectio

Phase 3

• Conditions: Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent

• Registration Number: CTRI/2017/09/009945
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age from 2.00

Age to 18.00

Gender both

Details:

1 Males and non-pregnant non lactating females

2 Weight at Screening : Cohort 1 (adolescents 12 to <18 years, > 35 kg):TAF 25 mg QD orally once daily for 24 Weeks

Cohort 2 Part A

Group 1: Age range- 6 to <12 years = 25 kg (=55lbs) TAF Dose 25 mg

Group 2: Age range- 6 to

<12 years = 17 kg to < 25kg (=37lbs to < 55lbs) TAF Dose 15 mg

Group 3: Age range- 2 to

<6 years <17 kg (=37lbs)TAF Dose TBD

4 Willing and able to provide written informed consent or assent or child and parent or legal guardian

5 Documented evidence of CHB eg HBsAg positive for more than or equal to 6 months

6 HBeAg-positive, or HBeAg-negative, chronic HBV infection

with all of the following:

a) Screening HBV DNA = 2 × 104 IU/mL

b) Screening serum ALT > 45 U/L ( >1.5 × ULN: 30 U/L) and

= 10 × ULN (by central laboratory range)

7 Treatment-naive or treatment experienced will be eligible for

Enrolment

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 more than or equal to 80 mL per min per 1.73m2 using the Schwartz formula

10 Normal ECG

Exclusion Criteria

1 Females who are breastfeeding

2 Males and females of reproductive potential who are unwilling to use an effective protocol-specified methods of contraception during

the study

3 Coinfection with hepatitis C virus, HCV, HIV or hepatitis D virus

4 Evidence of hepatocellular carcinoma

5 Any history of or current evidence of clinical hepatic

decompensation

6 Abnormal hematological and biochemical parameters, including:

a) Hemoglobin < 10 g/dL

b) Absolute neutrophil count < 1500/mm3

c) Platelets = 100,000/mm3

d) AST or ALT > 10 × ULN (by central laboratory range)

e) Total bilirubin > 2.5 × ULN

f) Albumin < 3.0 g/dL

g) INR > 1.5 × ULN (unless on stable anticoagulant regimen)

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, Individuals under evaluation for possible malignancy are not eligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified