Risk of Hepatitis Flare in Patients With Previous Hepatitis B Virus Exposure Amongst Patients

NCT04356404 | Terminated

• 1 other identifier: HEP-FLARE_Protocol_20210604_V5
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the risk of hepatitis flare in patients with previous hepatitis B virus exposure amongst patients on immunosuppressive and biological modifier therapies

Conditions

Occult Hepatitis B; Biological Substance; Adverse Effect; Immunosuppression

Keywords

Occult Hepatitis B infection; Biologics; Immunosuppressants

Outcome Measures

Primary Outcomes (1)

• Rate of hepatitis flare

  Hepatitis flare, defined as ALT \>2xULN IU/L, according to the Asia Pacific Association for the Study of the Liver (APASL) definition while on biological modifier therapy. The upper limit of normal (ULN) was defined as 40 IU/L by APASL.

  24 months

Secondary Outcomes (4)

• Rate of severe hepatitis flare

  24 months

• Rate of icteric flare

  24 months

• Rate of HBsAg seroreversion

  24 months

• Risk factors associated with development of hepatitis flare

  24 months

Study Arms (1)

Prospective group

Patients will be followed up until development of hepatitis flare or at 2 years after study recruitment. We plan to recruit 150 patients for the prospective cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with previous HBV exposure who are already on biological modifier therapies and who will be newly started on biological modifier therapies in the Department of Medicine and Therapeutics, Prince of Wales Hospital and Department of Medicine, University Malaya Medical Centre will be recruited.

You may qualify if:

• Age ≥ 18 years old at the time of starting biological modifier therapies or at the time of recruitment
• Positive for anti-HBc OR
• Positive for anti-HBs and born before year 1988

You may not qualify if:

• Known HBV carrier with HBsAg positive
• Concomitant HCV and/ or HIV infection
• Already on HBV anti-viral
• Refuse to consent
• Baseline ALT \> 80 IU/ml

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University of Malaya: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

• WingYan Mak, MRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: May 1, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)