Hepatitis B, Chronic Clinical Trial
Official title:
A Prospective Randomized Clinical Trial of Combination Sequential Treatment With Y Peginterferon Alfa-2b and ETV (Entecavir) in CHB (Chronic Hepatitis B) Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to assess the efficacy and safety of combination and sequential treatment with Y peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides experienced. Patients were randomized to one of 3 groups to receive different antiviral treatment.
Patients who have been pretreated with and responded to one or two nucleotides or nucleosides for at least one year, with HBV (Hepatitis B Virus) DNA less than 1000 copies/ml and HBsAg less 3000 IU/ml were randomized to one of 3 groups, to receive Y peginterferon Alfa-2b 180mcg/week for 96 weeks, entecavir 0.5 mg po daily for 48 weeks plus GMCSF (Granulocyte-macrophage colony stimulating factor) for 48 weeks, or Y peginterferon Alfa-2b 180mcg/week for 96 weeks and entecavir 0.5 mg po daily for 48 weeks, or only ETV for 96 weeks. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03272009 -
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
|
Phase 1 | |
| Recruiting |
NCT01456312 -
HBsAg Related Response Guided Therapy
|
Phase 4 | |
| Terminated |
NCT01886300 -
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
|
N/A | |
| Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
Phase 1 | |
| Completed |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
| Terminated |
NCT00460850 -
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
|
Phase 4 | |
| Completed |
NCT00536263 -
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
|
Phase 3 | |
| Completed |
NCT03681132 -
The Norwegian Nucleoside Analogue Stop Study
|
Phase 4 | |
| Active, not recruiting |
NCT05473806 -
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
|
Phase 4 | |
| Withdrawn |
NCT01179594 -
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
|
Phase 4 | |
| Recruiting |
NCT05057065 -
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
|
||
| Completed |
NCT04439539 -
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
| Withdrawn |
NCT03125213 -
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
|
Phase 2 | |
| Active, not recruiting |
NCT04782375 -
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
|
Phase 4 | |
| Withdrawn |
NCT05550519 -
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
|
Early Phase 1 | |
| Completed |
NCT02693652 -
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT04160897 -
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
|
||
| Active, not recruiting |
NCT02588937 -
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
|
Phase 4 | |
| Completed |
NCT02612506 -
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT02267473 -
Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
|