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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997944
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Beijing Bio-Fortune Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Biological: Human Serum ALbumin/interferon alpha2a Biological: Pegasys Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
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
600,750 or 900 mcg dosing every 2 weeks

Active Comparator: Pegasys
Peginteferon 180 mcg multiple dose S.C.
Biological: Pegasys
180 mcg dosing every week




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997944


Locations
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China, Jilin
Jilin University First Affiliated Hospital
Changchun, Jilin, China, 130021
Sponsors and Collaborators
Beijing Bio-Fortune Ltd.
Investigators
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Principal Investigator: Junqi Niu, MD Jilin University First Affiliated Hospital
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Responsible Party: Beijing Bio-Fortune Ltd.
ClinicalTrials.gov Identifier: NCT01997944    
Other Study ID Numbers: 921302
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs