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Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588077
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Thuluvath, MD, Mercy Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Cirrhosis, Liver Chronic Liver Disease Biological: Heplisav-B Injectable Product, 2-dose regimen Biological: Heplisav-B Injectable Product, 3-dose regimen Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cirrhosis, 3-dose regimen
Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.
Biological: Heplisav-B Injectable Product, 3-dose regimen
Investigators will randomly assign patients into a 3-dose regimen.
Other Name: 3-dose regimen

Active Comparator: Cirrhosis, 2-dose regimen
Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.
Biological: Heplisav-B Injectable Product, 2-dose regimen
Investigators will randomly assign patients into a 2-dose regimen.
Other Name: 2-dose regimen

Experimental: Non cirrhosis, 3-dose regimen
Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.
Biological: Heplisav-B Injectable Product, 3-dose regimen
Investigators will randomly assign patients into a 3-dose regimen.
Other Name: 3-dose regimen

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.
Biological: Heplisav-B Injectable Product, 2-dose regimen
Investigators will randomly assign patients into a 2-dose regimen.
Other Name: 2-dose regimen




Primary Outcome Measures :
  1. The rates of seroconversion after two doses of Heplisav-B given at 0 and 4 weeks versus three doses of Heplisav-B given at 0, 4 weeks, and 8 weeks. [ Time Frame: 12 weeks after completing Heplisav-B series with two doses or three doses ]
    The rates of seroconversion is defined as an HBsAg antibody concentration ≥ 10 mIU/ml.


Secondary Outcome Measures :
  1. Factors are associated with a lower likelihood of achieving immunogenicity, such as age, race, MELD scores, etiologies of cirrhosis, comorbidity, immunosuppressive drugs. Those information will be measured or described descriptively by chart review. [ Time Frame: Through study completion, an average of 1 year ]

    Age (years) Race (White, Black, Other). MELD (Model For End-Stage Liver Disease) score: 6-40

    Etiologies of cirrhosis will include:

    Nonalcoholic Fatty Liver Disease (Yes/No). Hepatitis C (Yes/No). Alcohol induced Liver Disease (Yes/No). Autoimmune Hepatitis (Yes/No). Primary Biliary Cholangitis (Yes/No). Primary Sclerosing Cholangitis (Yes/No).

    Comorbidity will include:

    Chronic obstructive pulmonary disease (Yes/No). Diabetes mellitus (Yes/No). Hypertension (Yes/No). Coronary artery disease (Yes/No). Acute renal injury (Yes/No). Chronic renal disease (Yes/No). Obesity (Yes/No). The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. A BMI of 30 and higher is considered obese. Immunosuppressive drugs (Yes/No).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine.
  • Those who had previous exposure to hepatitis B.
  • Post liver transplant patients.
  • Less than 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588077


Contacts
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Contact: CHAU TO, MD (714)-400-1331 cto@mdmercy.com
Contact: Paul Thuluvath, MD (410)-332-9308 pthuluv@mdmercy.com

Locations
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United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: CHAU TO, MD    714-400-1331    cto@mdmercy.com   
Contact: PAUL THULUVATH, MD    (410)-332-9308    pthuluv@mdmercy.com   
Sponsors and Collaborators
Mercy Medical Center
Investigators
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Principal Investigator: Paul Thuluvath, MD Mercy Medical Center
  Study Documents (Full-Text)

Documents provided by Paul Thuluvath, MD, Mercy Medical Center:
Informed Consent Form  [PDF] September 11, 2020

Additional Information:
Publications of Results:
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Responsible Party: Paul Thuluvath, MD, MD, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT04588077    
Other Study ID Numbers: 2020-24
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Paul Thuluvath, MD, Mercy Medical Center:
hepatitis B vaccine
Heplisav-B
cirrhosis
chronic liver disease
2 dose regimen
3 dose regimen
non responder
poor responder
no response
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Cirrhosis
Liver Diseases
Fibrosis
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes