Hepatitis B Clinical Trial
Official title:
Establishing Monitoring Strategies in Individuals With Prior Hepatitis B Virus Exposure Undergoing Anti-CD20 Antibody Containing Chemotherapy: A Prospective Observational Study
NCT number | NCT03155984 |
Other study ID # | UW15-384 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2013 |
Est. completion date | December 1, 2017 |
Verified date | May 2018 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing antiviral therapy and the interval of clinical monitoring is uncertain. 25% of the Hong Kong population has prior HBV exposure. The investigators plan monitor this cohort of patients and determine (1) the optimal time point for starting antiviral therapy based on the progression of HBV reactivation, and (2) the optimal interval of clinical monitoring.
Status | Completed |
Enrollment | 83 |
Est. completion date | December 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance score of =2. 3. HBsAg-negative, anti-HBc positive patient receiving anti-CD20 containing chemotherapy with or without antibody to the hepatitis B surface antigen (anti-HBs). 4. Baseline normal serum alanine amiontransferase (ALT) (=30 U/L for men, =19 U/L for women). Exclusion Criteria: 1. Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis. 2. Significant alcohol intake (>30 grams per day). 3. History of prior anti-HBV therapy, hematopoietic stem-cell transplantation, anti-CD20 antibody therapy, anti-CD52 antibody therapy or anti-tumour necrosis factor antibody therapy. 4. Baseline detectable HBV DNA (=10 IU/mL). These patients will be started on prophylactic entecavir. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HBV Reactivation | HBV DNA >= 10 IU/mL | From commencement of anti-CD20 antibody therapy for up to 2 years | |
Secondary | HBV-related hepatitis | ALT >60 U/L for men; >38 U/L for women; and HBV DNA >2,000 IU/mL | From commencement of anti-CD20 antibody therapy for up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |