NCT01997944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

November 21, 2013

Last Update Submit

November 14, 2014

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    18 weeks

Secondary Outcomes (7)

  • Decrease of HBV DNA

    18 weeks

  • AUCss

    18 weeks

  • Css_av

    18 weeks

  • Css_min

    18 weeks

  • Css-max

    18 weeks

  • +2 more secondary outcomes

Study Arms (2)

Human Serum Albumin/interferon alpha2a

EXPERIMENTAL

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

Biological: Human Serum ALbumin/interferon alpha2a

Pegasys

ACTIVE COMPARATOR

Peginteferon 180 mcg multiple dose S.C.

Biological: Pegasys

Interventions

Human Serum ALbumin/interferon alpha2aBIOLOGICAL

600,750 or 900 mcg dosing every 2 weeks

Human Serum Albumin/interferon alpha2a
PegasysBIOLOGICAL

180 mcg dosing every week

Pegasys

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jilin University First Affiliated Hospital

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Serum Albumin, HumanInterferon alpha-2peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood ProteinsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Junqi Niu, MD

    Jilin University First Affiliated Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

CN(1)