A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B
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.
1 other identifier
interventional
110
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2014
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 4, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJanuary 25, 2017
August 1, 2016
1.7 years
January 4, 2015
January 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of HBeAg seroconversion at the end of treatment
week 48
Secondary Outcomes (5)
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
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48
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
treatment week 12, 24, 36, and 48
Percentage of ALT normalization at week 24, 36 and 48
week 24 ,36 and 48
Study Arms (2)
Arm A
ACTIVE COMPARATORYpeginterferon alfa-2b,sc. Qw. 48 weeks.
Arm B
EXPERIMENTALYpeginterferon 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.
Interventions
Eligibility Criteria
You may qualify if:
- yrs≤age≤65yrs.
- ≤BMI(body mass index)≤28.
- HBsAg positive≥6 months.
- Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
- ULN≤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.
You may not qualify if:
- 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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiamen Amoytop Biotech Co., Ltd.lead
- Peking University First Hospitalcollaborator
Study Sites (12)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2015
First Posted
January 6, 2015
Study Start
June 1, 2014
Primary Completion
February 1, 2016
Study Completion
August 1, 2016
Last Updated
January 25, 2017
Record last verified: 2016-08