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

NCT ID: NCT02332473

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-08-31

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: ACTIVE_COMPARATOR

Ypeginterferon alfa-2b

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Ypeginterferon alfa-2b

Intervention Type: DRUG

Granulocyte-macrophage colony stimulating factor

Intervention Type: DRUG

Interventions

Ypeginterferon alfa-2b

Intervention Type: DRUG

Granulocyte-macrophage colony stimulating factor

Intervention Type: DRUG

Other Intervention Names

peginterferon alfa-2b; GM-CSF

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hosopital

Beijing, Beijing Municipality, China

Fuzhou Infectious Disease Hospital

Fuzhou, Fujian, China

Xiamen Hospital of T.C.M

Xiamen, Fujian, China

Nanfang Hospital

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Tongji Hospital, Huazhong University of Science & Technology

Wuhan, Hubei, China

Xiangya Second Hospital, Central-south University

Changsha, Hunan, China

Shenyang Sixed People's Hospital

Shenyang, Liaoning, China

Ruijing Hospital

Shanghai, Shanghai Municipality, China

Xijing Hospital

Xi’an, Shanxi, China

First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

TB1405IFN

Identifier Type: -

Identifier Source: org_study_id