NCT03294798

Brief Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

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

June 13, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

September 21, 2017

Last Update Submit

March 29, 2021

Conditions

Hepatitis B Virus

Outcome Measures

Primary Outcomes (1)

  • the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment

    HBV DNA

    17 weeks

Secondary Outcomes (4)

  • the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment

    4 weeks and 17 weeks

  • the recovery rates of ALT after treatment

    17 weeks

  • the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment

    17 weeks

  • the rates of HBsAg decrease from baseline after treatment

    17 weeks

Study Arms (2)

Human Serum Albumin/interferon alpha2b

EXPERIMENTAL

Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.

Biological: Human Serum Albumin/interferon alpha2b fusion protein

Pegasys

ACTIVE COMPARATOR

Pegasys 180 mcg, once per week

Biological: Pegasys

Interventions

Human Serum Albumin/interferon alpha2b fusion proteinBIOLOGICAL

In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.

Human Serum Albumin/interferon alpha2b
PegasysBIOLOGICAL

In comparator group, each subject will recieve 180mcg once per week.

Pegasys

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HBV patients who have positive HBeAg or HBeAb
  • Must be healthy males or females between 18 to 60 years old
  • Must have a body mass index (BMI) of 18 to 30 kg/m2
  • HBV DNA≥2000 IU/mL
  • ALT≥1.3 ULN and ≤10 ULN

You may not qualify if:

  • Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time.
  • Participated in other clinical trials within a month.
  • Allergic to interferon.
  • T-Bil ≥2 ULN. ALB\<35g/L. PT≥4s.
  • Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab.
  • Organ transplant patients, except cornea or hair transplantation.
  • Other hepatopathy exclude NAFLD .
  • Drug addiction or alcohol dependence.
  • Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history.
  • Serious retinal disease.
  • Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder.
  • Autoimmune disease.
  • Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure.
  • WBC\<3×109/L or ANC\<1.5 ×109/L or PLT\<90 ×109/L or HGB\<ULN.
  • HCC or AFP\>100ng/mL.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

human serum albumin-interferon-alpha-2b fusion proteinpeginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • meixia wang, professor

    Beijing YouAn Hospital

    PRINCIPAL INVESTIGATOR

  • jun li, professor

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

  • liang chen, professor

    Shanghai Public Health Clinical Center

    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

September 21, 2017

First Posted

September 27, 2017

Study Start

June 13, 2017

Primary Completion

March 15, 2019

Study Completion

March 15, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

CN(1)