A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B
This trial has been completed.
|Condition||chronic hepatitis b|
|Treatments||ypeginterferon alfa-2b, granulocyte-macrophage colony stimulating factor|
|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|
|Beijing, China||Peking University First Hospital||completed|
|Beijing, China||Peking University People's Hosopital||completed|
|Fuzhou, China||Fuzhou Infectious Disease Hospital||completed|
|Xiamen, China||Xiamen Hospital of T.C.M||completed|
|Guangzhou, China||Nanfang Hospital||completed|
|Zhengzhou, China||Henan Provincial People's Hospital||completed|
|Wuhan, China||Tongji Hospital, Huazhong University of Science & Technology||completed|
|Changsha, China||Xiangya Second Hospital, Central-south University||completed|
|Shenyang, China||Shenyang Sixed People's Hospital||completed|
|Shanghai, China||Ruijing Hospital||completed|
|Xi'an, China||Xijing Hospital||completed|
|Wenzhou, China||First Affiliated Hospital of Wenzhou Medical College||completed|
|Intervention model||parallel assignment|
Percentage of HBeAg seroconversion at the end of treatment
time frame: week 48
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
All participants from 18 years up to 65 years old.
- 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.
- 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).
|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.|
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