Overview

This trial has been completed.

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

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Active Comparator)
Ypeginterferon alfa-2b,sc. Qw. 48 weeks.
ypeginterferon alfa-2b peginterferon alfa-2b
(Experimental)
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

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

Secondary Outcomes

Measure
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

All 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<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).

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 January 2017.
Information provided to ClinicalTrials.gov by Xiamen Amoytop Biotech Co., Ltd..