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CompletedNCT01997944Updated Nov 17, 2014

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

A Phase 1/2 interventional study of Human Serum ALbumin/interferon alpha2a and Pegasys in Chronic Hepatitis B, sponsored by Beijing Bio-Fortune Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-11-17.

Sponsored by Beijing Bio-Fortune Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Hepatitis B
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Beijing Bio-Fortune Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Human Serum Albumin/interferon alpha2a

    Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.

    Biological: Human Serum ALbumin/interferon alpha2a

  • Active comparator
    Pegasys

    Peginteferon 180 mcg multiple dose S.C.

    Biological: Pegasys

Interventions

  • BiologicalHuman Serum ALbumin/interferon alpha2a

    600,750 or 900 mcg dosing every 2 weeks

  • BiologicalPegasys

    180 mcg dosing every week

06

What researchers measure

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

07

Study locations

1 site
  • Jilin University First Affiliated Hospital
    Changchun, Jilin 130021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997944
Lead sponsor
Beijing Bio-Fortune Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2013
Start date
Nov 2013
Primary completion
Sep 2014
Completion
Nov 2014
Last update
Nov 17, 2014

Study contacts

Junqi Niu, MD
principal investigator · Jilin University First Affiliated Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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