Chronic Hepatitis B Clinical Trial
Official title:
An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY
The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.
- Korea is known to be an endemic area for HBV infection. Some studies have reported that
more than 95% of patients in Korea with chronic HBV have genotype C infection.
- Compared with other genotypes, genotype C is associated with increased viral loads,
higher histologic activity, more severe acute exacerbations, a longer viral clearance
phase and worse antiviral response to peg-interferon therapy.
- Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B
(CHB) patients with compensated and decompensated liver disease. However, a possibility
of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA
levels after termination of NAs administration. In addition, NA therapy has been
reported to have lower chance of HBsAg seroclearance compared to that with
immunomodulatory agents such as peginterferon.
- Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease.
However, a better understanding of HBV treatment with Pegasys® in the real-life
clinical setting in Korea can be helpful for decision of treatment strategy in the
future. Asian experience with Pegasys® therapy in CHB is limited. Study populations of
investigator-initiated trials consist of selected group with smaller number of Korean
patients. Therefore, long-term efficacy and safety data in real practice with Pegasys®
treatment in both HBeAg-positive and -negative Korean patients are necessary.
- In addition, the current proposed collected data study may be helpful to bring answers
to many unresolved issues: the antiviral efficacy and safety profiles in Korean CHB
patients who are mostly infected with solely genotype C HBV, a proper duration of
Pegasys® therapy post-treatment durability or accumulation of HBeAg
seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver
cirrhosis and liver cancer. In addition, this study aims to collect more data on the
efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients
with CHB.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04496882 -
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
|
Phase 4 | |
| Completed |
NCT04083716 -
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
|
Phase 1 | |
| Not yet recruiting |
NCT03038802 -
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
|
Phase 1/Phase 2 | |
| Completed |
NCT05310487 -
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
|
Phase 1 | |
| Recruiting |
NCT06070051 -
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
|
Phase 1 | |
| Terminated |
NCT05001022 -
A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects
|
Phase 1 | |
| Recruiting |
NCT04139850 -
The Establishment of Korean Hepatitis B Patients Cohort
|
||
| Recruiting |
NCT05343481 -
Efficacy of VTP-300 in Chronic Hepatitis B Infection
|
Phase 2 | |
| Not yet recruiting |
NCT05490836 -
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
|
N/A | |
| Recruiting |
NCT04543565 -
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
|
Phase 3 | |
| Active, not recruiting |
NCT02894918 -
A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs
|
Phase 4 | |
| Not yet recruiting |
NCT02793791 -
Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients
|
N/A | |
| Recruiting |
NCT02287857 -
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
|
N/A | |
| Recruiting |
NCT01965418 -
A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
|
Phase 4 | |
| Recruiting |
NCT01491295 -
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
|
Phase 4 | |
| Terminated |
NCT01872988 -
Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma
|
Phase 3 | |
| Recruiting |
NCT01487876 -
Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients
|
Phase 2 | |
| Not yet recruiting |
NCT01436539 -
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
|
Phase 4 | |
| Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A | |
| Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A |