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Trial record 154 of 342 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

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ClinicalTrials.gov Identifier: NCT03294798
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Biological: Human Serum Albumin/interferon alpha2b fusion protein Biological: Pegasys Phase 1

Detailed Description:
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose & Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Human Serum Albumin/interferon alpha2b
Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.
Biological: Human Serum Albumin/interferon alpha2b fusion protein
In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
Active Comparator: Pegasys
Pegasys 180 mcg, once per week
Biological: Pegasys
In comparator group, each subject will recieve 180mcg once per week.



Primary Outcome Measures :
  1. the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment [ Time Frame: 17 weeks ]
    HBV DNA


Secondary Outcome Measures :
  1. the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment [ Time Frame: 4 weeks and 17 weeks ]
    HBV DNA

  2. the recovery rates of ALT after treatment [ Time Frame: 17 weeks ]
    ALT

  3. the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment [ Time Frame: 17 weeks ]
    HBsAg/HBeAg

  4. the rates of HBsAg decrease from baseline after treatment [ Time Frame: 17 weeks ]
    HBsAg



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Chronic kidney disease or sCr>ULN.
  • Lactating women or pregnancy.
  • Cardiovascular and cerebrovascular events within 6 months.
  • Neurological or psychiatric disease or family history.

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): NCT03294798


Contacts
Contact: meixia wang, professor +86-010-83997181 wangmeixiad@163.com

Locations
China, Beijing
Beijing YouAn Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100069
Contact: Meixia Wang, Professor    +86-10-83997181    wangmeixiad@163.com   
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.
Investigators
Principal Investigator: 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

Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT03294798     History of Changes
Other Study ID Numbers: 9216-Ib
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs