NCT04405011 is a NA clinical trial of 24-week Entecavir in HBV/HCV Co-infection, sponsored by National Taiwan University Hospital.

Who is sponsoring NCT04405011?

NCT04405011 is sponsored by National Taiwan University Hospital.

What drugs are being tested in NCT04405011?

Interventions in NCT04405011: 24-week Entecavir, 12-week Entecavir.

What condition does NCT04405011 study?

NCT04405011 studies HBV/HCV Co-infection.

Is NCT04405011 still recruiting?

NCT04405011 is currently status unknown. Last updated 2 July 2020.

Last reviewed 2020-07-02 · How we verify

NCT04405011

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC

Status unknown NA Last updated 2 July 2020

What this trial tests

NA trial testing 24-week Entecavir in HBV/HCV Co-infection in 60 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
28 December 2020

28 December 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 August 2018
Primary completion	28 December 2020
Estimated completion	28 December 2020
Sites	2 locations across Taiwan

Drugs / interventions tested

24-week Entecavir — full drug profile →
12-week Entecavir — full drug profile →

Conditions studied

HBV/HCV Co-infection — all drugs for HBV/HCV Co-infection →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 70, any sex, with HBV/HCV Co-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HBV reactivation is common in HCV/HBV coinfected patients receiving DAA therapy for chronic hepatitis C. How to prevent HBV reactivation remains unclear. In this trial, we aim to investigate whether prophylactic nucleos(t)ide analogue (NUC) at the start of DAA could prevent HBV reactivation or not. And whether prolonged NUC prophylaxis (24 weeks) would be better than 12-week prophylaxis. This will be a three-arm, open-label, randomized, active controlled, study. Totally, 60 HBV/HCV co-infected treatment-naïve or treatment-experienced patients without decompensated liver cirrhosis will be included in this study. Group 1 patients (n=20) will receive 12-week ETV from the start of DAA therapy. Group 2 patients (n=20) will receive 24-week ETV from the start of DAA till 12 weeks after end of DAA. Group 3 patients (n=20) will not receive ETV during the period of DAA and will serve as controls. The rate of HBV reactivation and clinical reactivation will be compared among 3 groups of patients. Expected outcomes: The rate of HBV reactivation and clinical reactivation will be lower in the ETV prophylaxis group, and will be the lowest in the group receiving 24-week ETV prophylaxis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Hepatitis C Virus and Hepatitis B Virus Co-Infection.
Shih YF, Liu CJ. · · 2020 · cited 31× · PMID 32664198 · DOI 10.3390/v12070741
Entecavir Prevents HBV Reactivation During Direct Acting Antivirals for HCV/HBV Dual Infection: A Randomized Trial.
Cheng PN, Liu CJ, Chen CY, Tseng KC, et al · · 2022 · cited 16× · PMID 34864158 · DOI 10.1016/j.cgh.2021.11.032

Verify or expand the search:

Other National Taiwan University Hospital trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04405011 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
Last refreshed: 2 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04405011.

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