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Register:	ClinicalTrials.gov
Last refreshed on:	6 June 2022
Main ID:	NCT01263587
Date of registration:	14/12/2010
Prospective Registration:	No
Primary sponsor:	University of Pittsburgh
Public title:	Hepatitis B Research Network Adult Cohort Study HBRN
Scientific title:	Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)
Date of first enrolment:	December 2010
Target sample size:	2051
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01263587
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Canada	United States

Contacts

Name:	Steven Belle, PhD
Address:
Telephone:
Email:
Affiliation:	University of Pittsburgh

Key inclusion & exclusion criteria

The study population will be recruited from multi-site clinical centers in the United
States and Canada including primary care hospitals and community centers.

Inclusion criteria

- Written informed consent

- At least 18 years of age

- Hepatitis B surface antigen (HBsAg) positive and either:

- Pregnant

- Anti-Hepatitis D positive

- Diagnosed with acute Hepatitis B infection or experiencing a hepatitis flare

- Immune tolerant or immune active phenotype

- Potentially eligible for the Immune Regulation and Costimulation in Natural
History of Chronic Hepatitis B ancillary study (NCT01298037).

Exclusion Criteria:

- Hepatic decompensation

- Hepatocellular carcinoma (HCC)

- Liver transplantation

- Current hepatitis B antiviral treatment (except pregnant women and patients who are
anti-HDV positive)

- Known Human immunodeficiency virus (HIV) co-infection (patients with Hepatitis D (HDV)
or Hepatitis C (HCV) co-infection are not excluded).

- Medical or social condition which in the opinion of the investigator will interfere
with or prevent follow-up per protocol

- Unable or unwilling to return for follow-up visits

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Primary Outcome(s)

Death [Time Frame: up to 288 weeks]

Liver transplantation [Time Frame: up to 288 weeks]

Hepatic decompensation [Time Frame: up to 288 weeks]

Cirrhosis [Time Frame: up to 288 weeks]

Hepatocellular carcinoma (HCC) [Time Frame: up to 288 weeks]

Antigen loss: e and s [Time Frame: up to 288 weeks]

Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare [Time Frame: up to 288 weeks]

Secondary Outcome(s)

Secondary ID(s)

A-DK-3002-001

P30DK050306

UL1TR000004

M01RR000040

U01DK082864

U01DK082867

UL1TR000058

U01DK082927

U01DK082944

U01DK082863

U01DK082872

U01DK082943

UL1TR001111

U01DK082843

U01DK082874

U01DK082923

DK082864

U01DK082871

UL1RR024986

U01DK082866

U01DK082919

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Research Resources (NCRR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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