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Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

NCT ID: NCT03933384

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2030-12-31

Brief Summary

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To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Detailed Description

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With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Conditions

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Hepatitis B Viral Hepatitis

Keywords

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Hepatitis B Viral Hepatitis Tenofovir alafenamide Entecavir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a study designed for non-inferior outcome comparisons for TAF and ETV. The eligible chronic hepatitis B patients are randomly assigned (1:1) to receive once-daily oral doses of TAF 25 mg or ETV 0.5mg.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tenofovir alafenamide group

Study subjects will receive tenofovir alafenamide 25 mg/tab once daily

Group Type ACTIVE_COMPARATOR

Tenofovir alafenamide

Intervention Type DRUG

Tenofovir alafenamide 25mg/tab once daily

Entecavir group

Study subjects will receive entecavir 0.5 mg/tab once daily

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

Entecavir 0.5mg/tab once daily

Interventions

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Tenofovir alafenamide

Tenofovir alafenamide 25mg/tab once daily

Intervention Type DRUG

Entecavir

Entecavir 0.5mg/tab once daily

Intervention Type DRUG

Other Intervention Names

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Vemlidy Baraclude

Eligibility Criteria

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Inclusion Criteria

1. Patients more than 20 years old
2. Chronic hepatitis B patients
3. Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria

1. Decompensated liver disease (Child-Pugh B \&C)
2. End stage renal disease (eGRF \< 15 ml/min/1.73m2)
3. Prior use of nucleot(s)ide analogues for chronic hepatitis B
4. Prior use of interferon for chronic hepatitis B within six months
5. Known history of human immunodeficiency virus or hepatitis C virus co-infection
6. Concurrent other uncontrolled malignancy
7. Women in pregnancy or lactation
8. Cannot conform to the study protocol of this study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Teng-Yu Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teng-Yu Lee, MD, PhD

Role: STUDY_CHAIR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Teng-Yu Lee, MD, PhD

Role: CONTACT

Phone: 886-4-23592525

Email: [email protected]

Hsin-Ju Tsai, MD

Role: CONTACT

Phone: 886-4-23592525

Email: [email protected]

Facility Contacts

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Teng-Yu Lee, MD, PhD

Role: primary

References

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Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006 Oct;45(4):529-38. doi: 10.1016/j.jhep.2006.05.013. Epub 2006 Jun 23.

Reference Type BACKGROUND
PMID: 16879891 (View on PubMed)

Chen DS, Sung JL. Hepatitis B virus infection on Taiwan. N Engl J Med. 1977 Sep 22;297(12):668-9. doi: 10.1056/NEJM197709222971213. No abstract available.

Reference Type BACKGROUND
PMID: 757978 (View on PubMed)

Ni YH, Chang MH, Wu JF, Hsu HY, Chen HL, Chen DS. Minimization of hepatitis B infection by a 25-year universal vaccination program. J Hepatol. 2012 Oct;57(4):730-5. doi: 10.1016/j.jhep.2012.05.021. Epub 2012 Jun 2.

Reference Type BACKGROUND
PMID: 22668640 (View on PubMed)

Chiang CJ, Yang YW, Chen JD, You SL, Yang HI, Lee MH, Lai MS, Chen CJ. Significant reduction in end-stage liver diseases burden through the national viral hepatitis therapy program in Taiwan. Hepatology. 2015 Apr;61(4):1154-62. doi: 10.1002/hep.27630. Epub 2015 Feb 10.

Reference Type BACKGROUND
PMID: 25476749 (View on PubMed)

Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.

Reference Type BACKGROUND
PMID: 29405329 (View on PubMed)

European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

Reference Type BACKGROUND
PMID: 28427875 (View on PubMed)

Kang L, Pan J, Wu J, Hu J, Sun Q, Tang J. Anti-HBV Drugs: Progress, Unmet Needs, and New Hope. Viruses. 2015 Sep 15;7(9):4960-77. doi: 10.3390/v7092854.

Reference Type BACKGROUND
PMID: 26389937 (View on PubMed)

Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, DeHertogh D, Wilber R, Zink RC, Cross A, Colonno R, Fernandes L; BEHoLD AI463027 Study Group. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1011-20. doi: 10.1056/NEJMoa051287.

Reference Type BACKGROUND
PMID: 16525138 (View on PubMed)

Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

Reference Type BACKGROUND
PMID: 19052126 (View on PubMed)

van Bommel F, Wunsche T, Mauss S, Reinke P, Bergk A, Schurmann D, Wiedenmann B, Berg T. Comparison of adefovir and tenofovir in the treatment of lamivudine-resistant hepatitis B virus infection. Hepatology. 2004 Dec;40(6):1421-5. doi: 10.1002/hep.20464.

Reference Type BACKGROUND
PMID: 15565615 (View on PubMed)

Tsai HJ, Chuang YW, Lee SW, Wu CY, Yeh HZ, Lee TY. Using the chronic kidney disease guidelines to evaluate the renal safety of tenofovir disoproxil fumarate in hepatitis B patients. Aliment Pharmacol Ther. 2018 Jun;47(12):1673-1681. doi: 10.1111/apt.14682. Epub 2018 Apr 25.

Reference Type BACKGROUND
PMID: 29696665 (View on PubMed)

Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

Reference Type BACKGROUND
PMID: 23732715 (View on PubMed)

Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

Reference Type BACKGROUND
PMID: 28404091 (View on PubMed)

Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.

Reference Type BACKGROUND
PMID: 28404092 (View on PubMed)

Other Identifiers

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106DHA0500150

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CF18341A

Identifier Type: -

Identifier Source: org_study_id