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NCT Number: NCT01997944

Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jilin University First Affiliated Hospital

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, aged 18-75 years
  • Chronic HBV infection (serum HBsAg detectable for > 6 months)
  • Serum HBeAg positive with HBV DNA >10^6copies/mL (or >20,000 IU/mL),orSerum HBeAg negative with HBV DNA >10^5copies/mL (or >2,000 IU/mL)
  • Serum ALT must be > 2 x ULN but below 10 x ULN

Exclusion criteria

  • Steroid treatment or immunosuppression 3 months prior to entry.
  • Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
  • Active lung disease or history of interstitial lung disease.
  • Hb< LLN or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 ,or WBC<3000/mm3 .
  • Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
  • Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
  • Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
  • History of thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Human Serum ALbumin/interferon alpha2a

Biological

600,750 or 900 mcg dosing every 2 weeks

Pegasys

Biological

180 mcg dosing every week

Primary outcomes

  1. Number of adverse events

    Time frame: 18 weeks

Secondary outcomes

  1. Decrease of HBV DNA

    Time frame: 18 weeks

  2. AUCss

    Time frame: 18 weeks

  3. Css_av

    Time frame: 18 weeks

  4. Css_min

    Time frame: 18 weeks

  5. Css-max

    Time frame: 18 weeks

  6. T1/2

    Time frame: 18 weeks

  7. Tmax

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Beijing Bio-Fortune Ltd.

Industry

Registry information

Official study title

Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2013
Registry last updated
Nov 17, 2014

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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