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NCT Number: NCT01143662

Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

302 Military Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:18~60 years.
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
  • Serum HBsAg positive for at least 6 months.
  • Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
  • 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

Exclusion criteria

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
  • WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, HEV.
  • Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • Evidence of hepatic decompensation.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.

Treatment and study plan

Ypeginterferon alfa-2b

Drug

sc, qw, for 48 weeks.

Peginterferon alfa-2a

Drug

sc, qw, for 48 weeks.

Other names: Pegasys

Primary outcomes

  1. Efficacy

    Time frame: week 24 from treatment start

    • Average of HBV DAN decline level at week 24.
    • Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.

Secondary outcomes

  1. Efficacy

    Time frame: week 12, 24, 48 from treatment start and week 24 after treatment

    • Average of HBV DNA decline level at week 12, 48 and 72.
    • Proportion of patients with HBV DNA undetectable at week 48 and 72.
    • Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.
    • Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.
    • Proportion of patients with ALT normalization at week 24 and 48.

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Peking University First Hospital

Registry information

Official study title

A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 14, 2010
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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