Chronic HBV Infection Clinical Trial
Official title:
A Study on Antiviral Treatment of Chronic Hepatitis B in Children (Sprout Project)
There are nearly 2 million HBsAg-positive children who are in urgent need of professional diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood liver disease. After infected with HBV virus, some children will develop disease progression, and some even develop cirrhosis and/or liver cancer. In pediatric liver cancer cases, up to 34% ~ 95% are caused by HBV infection. Although two major classes of drugs have been approved for the treatment of chronic hepatitis B in adults, and there are multiple guidelines worldwide for the management of HBV infection in adults, there is lack of guidelines specifically for the management of children with HBV infection. In addition, the treatment of chronic hepatitis B in children faced great difficulties due to the lack of evidence-based medical evidence for antiviral treatment of chronic hepatitis B in children and fewer drugs approved for anti-HBV treatment in children. The timing of treatment, medications, and clinical management strategies are all controversial. This study ( Sprout project)，is a multicenter, prospective, cohort study in China, aiming to explore and optimize the antiviral treatment regimen for children with HBV infection, to provide evidence-based medical for antiviral treatment, and to provide basis evidence for the standardized management of children infection with HBV in China. The study is expected to enroll 1900 pediatric patients with HBV infection, and patient will received one of the three following treatment Strategies: nucleoside monotherapy, peginterferon α- combined with nucleoside therapy, or peginterferon α-pulse therapy combined with nucleoside therapy, according to their illness state and desire, and the safety and efficacy will be evaluated.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04470388 -
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
|
Phase 1 | |
| Completed |
NCT05019040 -
Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT01943799 -
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
|
Phase 2 | |
| Completed |
NCT05468060 -
Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04008004 -
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
|
Phase 1 | |
| Active, not recruiting |
NCT05734807 -
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
|
Phase 2 | |
| Completed |
NCT06029634 -
Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
|
||
| Recruiting |
NCT04147208 -
Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
|
Phase 2 | |
| Completed |
NCT03909191 -
Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
|
||
| Completed |
NCT03664518 -
to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection
|
Phase 2 | |
| Completed |
NCT05542979 -
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
|
Phase 1 | |
| Active, not recruiting |
NCT03903796 -
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
|
Phase 3 | |
| Completed |
NCT05851261 -
Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects
|
Phase 1 |