An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

• Sponsor: Target PharmaSolutions, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03692897
• Collaborator: (none)
• Enrollment: 5,000
• Locations: 27
• Anticipated Duration (Months): 86.7
• Patients Per Site: 185.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B; Hepatitis; Liver Diseases	Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
• Actual Study Start Date: Oct 11, 2018
• Anticipated Primary Completion Date: Jan 1, 2026
• Anticipated Study Completion Date: Jan 1, 2026

Outcome Measures

Primary Outcome Measures

1. Natural history of CHB: Characteristics of CHB infection [Up to 10 years]

2. Natural history of CHB: Participant demographics [Up to 10 years]

3. Natural history of CHB: Treatment use [Up to 10 years]

4. Natural history of CHB: Treatment response [Up to 10 years]

5. Time point of clinical response [Every 6 months for 10 years]

6. Natural history of CHB: Disease progression [Up to 10 years]

7. Adverse event frequency and severity [Up to 10 years]

Secondary Outcome Measures

1. Reasons for treatment discontinuation [Up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion

1. Male or female patients, age ≥18 years

2. Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis

Exclusion

1. Inability to provide written informed consent

2. Known history of Human Immunodeficiency Virus (HIV)

3. History of liver transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medical Center Phoenix	Phoenix	Arizona	United States	85006
2	Asian Pacific Liver Center at Coalition of Inclusive Medicine	Los Angeles	California	United States	90020
3	California Liver Research Institute	Pasadena	California	United States	91105
4	UC Davis GI/Hepatology Clinical Trials Unit	Sacramento	California	United States	95817
5	Silicon Valley Research Institute	San Jose	California	United States	95128
6	Yale University Digestive Diseases	New Haven	Connecticut	United States	06520
7	Medstar Georgetown University Hospital	Washington	District of Columbia	United States	20007
8	University of Florida	Gainesville	Florida	United States	32610-072
9	University of Miami, Schiff Center for Liver Disease	Miami	Florida	United States	33136
10	Atlanta Gastroenterology	Atlanta	Georgia	United States	30308
11	Consultative Gastroenterology	Atlanta	Georgia	United States	30308
12	Rush Universtiy Medical Center	Chicago	Illinois	United States	60612
13	University of Chicago	Chicago	Illinois	United States	60637
14	Mercy Medical Center	Baltimore	Maryland	United States	21202
15	University of Michigan	Ann Arbor	Michigan	United States	48109
16	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota	United States	55446
17	Rutgers, Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
18	Dreamwork Medical, PLLC	Flushing	New York	United States	11354
19	Northwell Health Center for Liver Diseases and Transplantation	Manhasset	New York	United States	11030
20	NYU Langone Health	New York	New York	United States	10016
21	Columbia University Medical Center	New York	New York	United States	10032
22	UNC Liver Center	Chapel Hill	North Carolina	United States	27599
23	Digestive and Liver Disease Specialist	Norfolk	Virginia	United States	23502
24	Bon Secours Liver Institute of Richmond	Richmond	Virginia	United States	23226
25	Virginia Commonwealth University	Richmond	Virginia	United States	23298
26	Swedish Organ Transplant and Liver Center	Seattle	Washington	United States	98104
27	University of Washington/Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Target PharmaSolutions, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Target PharmaSolutions, Inc.
• ClinicalTrials.gov Identifier: NCT03692897
• Other Study ID Numbers: TARGET-HBV
• First Posted: Oct 2, 2018
• Last Update Posted: Jun 13, 2022
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Liver Diseases

Study Results

No Results Posted as of Jun 13, 2022