The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

NCT03308890 | Unknown Phase 4

• 1 other identifier: AI463-527
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Clinical relapse rate.

  Clinical relapse rate (HBV DNA\>2000 IU/ml and ALT\> 2x ULN) within 6 months after cessation of TDF or ETV consolidation treatment (up to 6 or 12 months on post-TDF therapy).

  Up to 24 months.

Secondary Outcomes (3)

• Severity of ATL flare

  Up to 24 months.

• Liver decompensation incidence

  Up to 24 months.

• Renal function changes

  Up to 24 months.

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

0.5mg Entecavir QD for 6 months after cessation of TDF and clinical observation for up to 6 months after the end of study follow-up.

Drug: 0.5mg Baraclude(entecavir)

Arm 2

ACTIVE COMPARATOR

0.5mg Entecavir QD for 12 months after cessation of TDF and clinical observation for up to 6 months after the end of study follow-up.

Drug: 0.5mg Baraclude(entecavir)

Arm 3

NO INTERVENTION

No consolidation arm and observation only and clinical observation for up to 6 months after the end of study follow-up.

Interventions

0.5mg Baraclude(entecavir) DRUG

0.5mg Baraclude (entecavir) QD for 6 months after cessation of TDF.

Arm 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>20 yrs old.
• No history of Lamivudine or telbivudine resistance.
• HBsAg positive for more than 6 months.
• HBeAg (-).
• HBeAg-negative CHB under TDF treatment for mora than 2 years and fulfilled APASL 2012 guideline's stopping rule: HBeAg (-): undetectable HBV DNA on 3 separate occasions at least 6 months apart.

You may not qualify if:

• Lamivudine/telbivudine resistance.
• HBeAg (+).
• HIV, HCV co-infection.
• Under immunosuppressant treatment (including steroid and biologics).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• China Medical University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Changhua Christian Hospital: collaborator

Related Publications (3)

• Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.

  PMID: 26563120 BACKGROUND

• Jeng WJ, Sheen IS, Chen YC, Hsu CW, Chien RN, Chu CM, Liaw YF. Off-therapy durability of response to entecavir therapy in hepatitis B e antigen-negative chronic hepatitis B patients. Hepatology. 2013 Dec;58(6):1888-96. doi: 10.1002/hep.26549. Epub 2013 Oct 17.

  PMID: 23744454 BACKGROUND

• Jeng WJ, Chen YC, Sheen IS, Lin CL, Hu TH, Chien RN, Liaw YF. Clinical Relapse After Cessation of Tenofovir Therapy in Hepatitis B e Antigen-Negative Patients. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1813-1820.e1. doi: 10.1016/j.cgh.2016.07.002. Epub 2016 Jul 9.

  PMID: 27404969 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi-Hsiang Huang, M.D. Ph.D.

CONTACT

+886-2-28757506; yhhuang@vghtpe.gov.tw

Chieh-Ju Lee, Master

CONTACT

+886-939859265; ssbugi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Gastroenterology & Hepatology

Model Details: Arm 1：0.5mg Entecavir QD for 6 months after cessation of TDF. Arm 2：0.5mg Entecavir QD for 12 months after cessation of TDF. Arm 3：No consolidation arm and observation only. Clinical observation for up to 6 months after the end of study follow-up for all arms.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 13, 2017
• Study Start: November 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: April 30, 2022
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share