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Nucleoside Reverse Transcriptase Inhibitor

TAF for Chronic Hepatitis B

Q: Are people currently being recruited for this experiment?

This study, which can be found on clinicaltrials.gov, is currently looking for patients to participate. The trial was first posted on November 1st 2016 and was last updated on November 15th 2022.

Q: How can I become a part of this clinical research?

This clinical trial is looking for 150 young patients that have previously contracted a virus. The age range for participants is 2-17 years old. There are a few key requirements that potential patients must meet in order to be eligible for the study, which are as follows: Cohort 1 = ≥ 35 kg (≥ 77 lbs), Willing and able to provide written informed consent/assent (child and parent/legal guardian), Males and non-pregnant, non-lactating females, Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs), Cohort 2 Group 2 = ≥ 14 kg to

Q: Are elderly people being welcomed into this clinical trial?

Children aged 2 to 17 may be eligible for this clinical trial. Out of the 400+ trials currently recruiting, less than 100 are seeking patients who fit this age bracket.

Q: How many patients are part of this experiment?

In order to properly conduct this trial, we need 150 participants that fit the bill in terms of our inclusion criteria. These children can receiving treatment at Rady Childrens Hospital in San Diego or Children's Mercy Hospital in <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City.

Q: Is this study widely available in urban areas?

This trial has 20 locations, with the principle ones being Rady Childrens Hospital in San Diego, <a href="https://www.withpower.com/clinical-trials/california">California</a>; Children's Mercy Hospital in <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>; and <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Children's Hospital - Main Hospital in Houston, Texas.

Q: Are there any dangers patients should know about before taking TAF?

While Phase 2 trials don't have data supporting efficacy, TAF's safety profile was still strong enough for it to receive a score of 2.

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:

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)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I have chronic hepatitis B.

Select...

I weigh at least 77 pounds.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24

Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24

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

+1 more

Secondary outcome measures

Acceptability of study drug

Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48

Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula

+33 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

Fatigue

Diarrhoea

Influenza

Nausea

Pain in extremity

Abdominal pain

Dyspepsia

Pharyngitis

Dizziness

Urinary tract infection

Hypertension

Gastrooesophageal reflux disease

Pancreatic carcinoma

Hepatocellular carcinoma

Ureterolithiasis

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

~2710

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,329 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,543 Total Patients Enrolled

Media Library

Tenofovir Alafenamide (TAF) (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02932150 — Phase 2

Chronic Hepatitis B Research Study Groups: TAF (Cohort 2 Group 3), Cohort 2 Placebo, Open-Label TAF, TAF (Cohort 1), Placebo (Cohort 1), TAF (Cohort 2 Group 1), TAF (Cohort 2 Group 2)

Chronic Hepatitis B Clinical Trial 2023: Tenofovir Alafenamide (TAF) Highlights & Side Effects. Trial Name: NCT02932150 — Phase 2

Tenofovir Alafenamide (TAF) (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02932150 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently being recruited for this experiment?

"This study, which can be found on clinicaltrials.gov, is currently looking for patients to participate. The trial was first posted on November 1st 2016 and was last updated on November 15th 2022."

Answered by AI

How can I become a part of this clinical research?

"This clinical trial is looking for 150 young patients that have previously contracted a virus. The age range for participants is 2-17 years old. There are a few key requirements that potential patients must meet in order to be eligible for the study, which are as follows: Cohort 1 = ≥ 35 kg (≥ 77 lbs), Willing and able to provide written informed consent/assent (child and parent/legal guardian), Males and non-pregnant, non-lactating females, Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs), Cohort 2 Group 2 = ≥ 14 kg to"

Answered by AI

Are elderly people being welcomed into this clinical trial?

"Children aged 2 to 17 may be eligible for this clinical trial. Out of the 400+ trials currently recruiting, less than 100 are seeking patients who fit this age bracket."

Answered by AI

How many patients are part of this experiment?

"In order to properly conduct this trial, we need 150 participants that fit the bill in terms of our inclusion criteria. These children can receiving treatment at Rady Childrens Hospital in San Diego or Children's Mercy Hospital in Kansas City."

Answered by AI

Is this study widely available in urban areas?

"This trial has 20 locations, with the principle ones being Rady Childrens Hospital in San Diego, California; Children's Mercy Hospital in Kansas City, Missouri; and Texas Children's Hospital - Main Hospital in Houston, Texas."

Answered by AI