The HOPE Study: Characterizing Patients With Hepatitis B and C

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Dec 13, 2016

Keywords

ClinConnect Summary

The HOPE Study is a clinical trial aimed at understanding and monitoring patients with chronic Hepatitis B and C, two viral infections that affect the liver. This study will collect samples from participants to help researchers learn more about how these diseases progress over time and to explore future treatment options. Participants will visit the study site once a year for up to 10 years, with the option for additional visits. There is also a special part of the study for patients with Hepatitis B who may receive a specific treatment called tenofovir alafenamide over two years, which involves blood tests and optional liver biopsies.

To participate, individuals must be at least 18 years old and have Hepatitis B or C, or have a history of these infections. Healthy volunteers without these infections are also welcome. Participants should be willing to provide samples for research and have a primary care provider. Importantly, the study is open to all genders and is currently actively recruiting participants. If you join, you can expect regular check-ups and the opportunity to contribute to important research that may help improve treatments for Hepatitis B and C in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years old
• • 2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; or hepatitis C infection and successfully treated with direct acting antiviral agents, with or without HIV infection; or healthy volunteer without history of HBV and/or C, nor HIV
• • 3. Willing to have samples stored for future research
• • 4. Must have an identifiable primary care provider or be in the process of establishing a primary care provider
• • 5. Willing to undergo HIV testing if not recently documented
• • 6. Inclusion in the HBV treatment sub-study will be dependent on eligibility to receive nucleos(t)ide analogue therapy according to standard-of-care.
• Exclusion Criteria:
• • 1. Unable to comply with research study visits
• • 2. Poor venous access not allowing screening laboratory collection
• • 3. Have any condition that the investigator considers a contraindication to study participation.
• • 4. HBV monoinfected participants with any contraindications to HBV treatment with nucleos(t)ide analogues will be ineligible to participate in the HBV treatment sub-study.
• • 5. Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study