NCT01997944CompletedPhase 1
Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Beijing Bio-Fortune Ltd.1 site in 1 country32 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of adverse events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Human Serum Albumin/interferon alpha2a
Experimental
Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C.
Intervention: Human Serum ALbumin/interferon alpha2a (Biological)
Pegasys
Active Comparator
Peginteferon 180 mcg multiple dose S.C.
Intervention: Pegasys (Biological)
Outcomes
Primary Outcomes
Number of adverse events
Time Frame: 18 weeks
Secondary Outcomes
- Css_min(18 weeks)
- Decrease of HBV DNA(18 weeks)
- AUCss(18 weeks)
- Css_av(18 weeks)
- Css-max(18 weeks)
- Tmax(18 weeks)
- T1/2(18 weeks)
Investigators
Study Sites (1)
Loading locations...
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