A Prospective Phase 2 Clinical Trial to Assess the Efficacy and Safety of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis Patients.

Xiamen Amoytop Biotech Co., Ltd.12 sites in 1 country110 target enrollmentJune 2014

ConditionsChronic Hepatitis B

InterventionsYpeginterferon alfa-2b Granulocyte-macrophage colony stimulating factor

DrugsYpeginterferon alfa-2b Granulocyte-macrophage colony stimulating factor

Overview

Phase: Phase 2
Intervention: Ypeginterferon alfa-2b
Conditions: Chronic Hepatitis B
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Enrollment: 110
Locations: 12
Primary Endpoint: Percentage of HBeAg seroconversion at the end of treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18yrs≤age≤65yrs.
•17≤BMI(body mass index)≤
•HBsAg positive≥6 months.
•Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
•2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening.
•Pregnancy test must be negative for female patients of childbearing potential. All patients take effective birth control measures during treatment and 6 months after the treatment.
•Agree to participate in the study and sign the informed consent.

Exclusion Criteria

•Pregnant or lactating females
•Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
•Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
•Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
•Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
•History or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures.
•Suffering from any other acute or chronic infectious disease.
•Mental disorder or physical disability, or family history of neurological and psychiatric disorders.
•Neutrophil count \<1500 cells/mm3, or platelet count \<90000 cells/mm3 at screening.
•Child-Pugh≥B, or other evidence of liver decompensation (e.g. serum albumin\<35g/L , prothrombin time\>3 seconds prolonged, serum bilirubin\>2ULN, prothrombin activity \<60%, history of liver decompensation).

Arms & Interventions

Arm A

Ypeginterferon alfa-2b,sc. Qw. 48 weeks.

Intervention: Ypeginterferon alfa-2b

Arm B

Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13.

Intervention: Ypeginterferon alfa-2b

Arm B

Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13.

Intervention: Granulocyte-macrophage colony stimulating factor

Outcomes

Primary Outcomes

Percentage of HBeAg seroconversion at the end of treatment

Time Frame: week 48

Secondary Outcomes

Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48(treatment week 12, 24, 36, and 48)
Percentage of ALT normalization at week 24, 36 and 48(week 24 ,36 and 48)
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48(week 12, 24, 36, and 48)
Percentage of HBsAg undetectable and seroconversion at the end of treatment(week 48)
Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48(week 12, 24, 36 and 48)