Optimizing HBV Management During Anti-CD20 Antibodies

NCT03155984 | Completed FDA Drug

• 1 other identifier: UW15-384
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Dysfunction; Immune Suppression; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBV Reactivation

  HBV DNA \>= 10 IU/mL

  From commencement of anti-CD20 antibody therapy for up to 2 years

Secondary Outcomes (1)

• HBV-related hepatitis

  From commencement of anti-CD20 antibody therapy for up to 2 years

Study Arms (1)

Anti-CD20 antibody

Patients with hematological malignancies receiving anti-CD20 antibody therapy

Drug: Anti-CD20 antibody

Interventions

Anti-CD20 antibody DRUG

All patients receiving anti-CD20 therapy (rituximab, ofanumumab, obinutuzumab) for hematological malignancies

Anti-CD20 antibody

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

HBsAg-negative anti-HBc positive individuals with hematological malignancies undergoing anti-CD20 containing chemotherapy.

You may qualify if:

• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
• HBsAg-negative, anti-HBc positive patient receiving anti-CD20 containing chemotherapy with or without antibody to the hepatitis B surface antigen (anti-HBs).
• Baseline normal serum alanine amiontransferase (ALT) (≤30 U/L for men, ≤19 U/L for women).

You may not qualify if:

• Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
• Significant alcohol intake (\>30 grams per day).
• 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.
• Baseline detectable HBV DNA (≥10 IU/mL). These patients will be started on prophylactic entecavir.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Liver Diseases; Hepatitis B

Condition Hierarchy (Ancestors)

Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Wai-Kay Seto, MD

  wkseto@hku.hk

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)