A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332473
• Other study ID #: TB1405IFN
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2015
• Last updated: January 23, 2017
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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<AFP<100ng/L at screening, retest 2 weeks later, and if AFP <50ng/L can enrolled, vs, excluded.

• Hepatocarcinoma or suffering from any other malignant tumor.

• Autoimmune disease(e.g., psoriasis, systemic lupus erythematosus).

• Moderate or severe hypertension, or mild hypertension without well controlled.

• With not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus).

• Drug abusing, or alcoholism.

• HBeAb positive or HBsAb positive at screening.

• Allergic to interferon, or GM-CSF, or any fragment of the study drug.

• Other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ypeginterferon alfa-2b

• Granulocyte-macrophage colony stimulating factor

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hosopital	Beijing	Beijing
China	Xiangya Second Hospital, Central-south University	Changsha	Hunan
China	Fuzhou Infectious Disease Hospital	Fuzhou	Fujian
China	Nanfang Hospital	Guangzhou	Guangdong
China	Ruijing Hospital	Shanghai	Shanghai
China	Shenyang Sixed People's Hospital	Shenyang	Liaoning
China	First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Tongji Hospital, Huazhong University of Science & Technology	Wuhan	Hubei
China	Xijing Hospital	Xi'an	Shanxi
China	Xiamen Hospital of T.C.M	Xiamen	Fujian
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of HBeAg seroconversion at the end of treatment		week 48
Secondary	Percentage of HBsAg undetectable and seroconversion at the end of treatment		week 48
Secondary	Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48		week 12, 24, 36 and 48
Secondary	Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48		week 12, 24, 36, and 48
Secondary	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
Secondary	Percentage of ALT normalization at week 24, 36 and 48		week 24 ,36 and 48