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Nucleoside Reverse Transcriptase Inhibitor

TAF for Chronic Hepatitis B

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and non-pregnant, non-lactating females

HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:

Must not have

Females who are pregnant or breastfeeding

Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at week 4 or 8 (cohort 1), and week 4, 8, or 12 (cohort 2)

Summary

This trial is testing a new drug, tenofovir alafenamide, to see if it is safe and effective in treating children and adolescents with chronic hepatitis B. The trial will consist of two parts, with the first part focused on collecting information about the new drug's pharmacokinetics in children, and the second part testing the safety and efficacy of the drug in children with chronic hepatitis B.

Who is the study for?

This trial is for children and teens with chronic hepatitis B. They must have had the virus for at least 6 months, weigh a minimum of 10 kg (22 lbs), and not be pregnant or breastfeeding. Participants should not have other liver diseases, HIV, HCV, HDV co-infections, cancer history within the last 5 years or substance abuse issues.

What is being tested?

The study tests Tenofovir Alafenamide (TAF) against a placebo to see how effective and safe it is in treating young people with chronic hepatitis B. It also aims to find out the right dose levels for children.

What are the potential side effects?

While specific side effects are not listed here, TAF may cause gastrointestinal discomforts like nausea or vomiting, headaches, fatigue and potential kidney problems as seen in adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man or a woman not pregnant or breastfeeding.

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I have chronic hepatitis B.

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I weigh at least 77 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am currently on medication that affects my immune system.

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I have a long-term liver condition not caused by hepatitis B.

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I have had a solid organ or bone marrow transplant.

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I have a history of or currently have severe liver problems.

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I am coinfected with HCV, HIV, or HDV.

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I have not been diagnosed with any cancer other than my current one in the last 5 years.

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I am not willing to use effective birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at week 4 or 8 (cohort 1), and week 4, 8, or 12 (cohort 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at week 4 or 8 (cohort 1), and week 4, 8, or 12 (cohort 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at week 4 or 8 (cohort 1), and week 4, 8, or 12 (cohort 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A

Secondary study objectives

Acceptability of study drug

PK Parameter: AUClast of TAF and TFV

PK Parameter: AUCtau of tenofovir (TFV)

+10 more

Side effects data

From 2022 Phase 3 trial • 426 Patients • NCT01940341

19%

Headache

14%

Nasopharyngitis

13%

Upper respiratory tract infection

11%

Arthralgia

Cough

Back pain

Diarrhoea

Fatigue

Influenza

Nausea

Abdominal pain

Pain in extremity

Dyspepsia

Pharyngitis

Urinary tract infection

Dizziness

Hypertension

Hepatocellular carcinoma

Pancreatic carcinoma

Ureterolithiasis

Gastrooesophageal reflux disease

Calculus ureteric

100%

80%

60%

40%

20%

Study treatment Arm

Double-blind Phase: TAF 25 mg

Double-blind Phase: TDF 300 mg

Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg

Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: TAF (Cohort 2 Group 3)Experimental Treatment1 Intervention

Participants (2 to \< 6 years) will receive TAF for 24 weeks as follows: * weight ≥ 10 kg to \< 14 kg (7.5 mg oral granules) * weight ≥ 14 kg to \< 25 kg (15 mg oral granules)

Group II: TAF (Cohort 2 Group 2)Experimental Treatment1 Intervention

Participants (6 to \< 12 years) weighing ≥ 14 kg to \< 25 kg will receive TAF 15 mg oral granules for 24 weeks

Group III: TAF (Cohort 2 Group 1)Experimental Treatment1 Intervention

Participants (6 to \< 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks

Group IV: TAF (Cohort 1)Experimental Treatment1 Intervention

Participants (12 to \< 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks

Group V: Open-Label TAFExperimental Treatment1 Intervention

Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.

Group VI: Cohort 2 PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.

Group VII: Placebo (Cohort 1)Placebo Group1 Intervention

Participants (12 to \< 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAF

2015

Completed Phase 3

~2740