Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.
Who is this study for? Adult patients with hepatitis and cirrhosis
What treatments are being studied? Heplisav-B
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- All the cirrhosis patients more than 18 years old presented to the hepatology clinic in Mercy Medical Center between 09/2020 and 07/2021 who do not have immunity against Hepatitis B (defined as anti-HBs titer \< 10 mIU/ml) will be recruited.
Locations
United States
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Contact Information
Primary
CHAU TO, MD
cto@mdmercy.com
(714)-400-1331
Backup
Paul Thuluvath, MD
pthuluv@mdmercy.com
(410)-332-9308
Time Frame
Start Date: 2020-09-14
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 200
Treatments
Experimental: Cirrhosis, 3-dose regimen
Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.
Active_comparator: Cirrhosis, 2-dose regimen
Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.
Experimental: Non cirrhosis, 3-dose regimen
Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.
Active_comparator: Non cirrhosis, 2-dose regimen
Investigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.
Related Therapeutic Areas
Sponsors
Leads: Mercy Medical Center