This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments ypeginterferon alfa-2b, granulocyte-macrophage colony stimulating factor
Phase phase 2
Sponsor Xiamen Amoytop Biotech Co., Ltd.
Collaborator Peking University First Hospital
Start date June 2014
End date February 2016
Trial size 110 participants
Trial identifier NCT02332473, TB1405IFN


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Ypeginterferon alfa-2b,sc. Qw. 48 weeks.
ypeginterferon alfa-2b peginterferon alfa-2b
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.
ypeginterferon alfa-2b peginterferon alfa-2b
granulocyte-macrophage colony stimulating factor GM-CSF

Primary Outcomes

Percentage of HBeAg seroconversion at the end of treatment
time frame: week 48

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 18yrs≤age≤65yrs. - 17≤BMI(body mass index)≤28. - 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). - Serum creatinine level >ULN in screening period. - Serum creatine kinase level >2ULN except for physiological factors (e.g., exercise). - AFP>100ng/L. If 50ng/L

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Xiamen Amoytop Biotech Co., Ltd..