Hepatitis B VirusPhase 1/2NCT03294798

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

A Phase 1/2 study testing Human Serum Albumin/interferon alpha2b fusion protein and Pegasys in people with Hepatitis B Virus, run by Tianjin SinoBiotech Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Hepatitis B Virus
What is being tested?: Human Serum Albumin/interferon alpha2b fusion protein and Pegasys
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteChina
Study dates: 13 Jun 2017to 15 Mar 2021
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069

Other trials in China

About this study

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

Read the 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.

Conditions: Hepatitis B Virus
Being tested: Human Serum Albumin/interferon alpha2b fusion protein, Pegasys
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03294798
Study group	Role	What they receive
Human Serum Albumin/interferon alpha2b	Experimental	Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks. Receives: Biological: Human Serum Albumin/interferon alpha2b fusion protein
Pegasys	Active comparator	Pegasys 180 mcg, once per week Receives: Biological: Pegasys

What is being measured

The primary outcome is the main question the study is designed to answer.

the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
HBV DNA
Measured: 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
HBV DNA
Measured: 4 weeks and 17 weeks
the recovery rates of ALT after treatment
ALT
Measured: 17 weeks
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
HBsAg/HBeAg
Measured: 17 weeks
the rates of HBsAg decrease from baseline after treatment
HBsAg
Measured: 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201715 Mar 2021

First posted27 Sep 2017
Study start13 Jun 2017
Primary completion15 Mar 2019
Study completion15 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294798
Sponsor's protocol ID: 9216-Ib
Status last verified: Mar 2021
First submitted: 21 Sep 2017
Last updated: 1 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03294798
Acronym / sponsor ID: 9216-Ib
Conditions: Hepatitis B Virus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Tianjin SinoBiotech Ltd.Industry (pharma, biotech, devices)
Study start: 13 Jun 2017 (actual)
Primary completion: 15 Mar 2019 (actual)
Study completion: 15 Mar 2021 (actual)
First posted: 27 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Human Serum Albumin/interferon alpha2b	Experimental	Biological: Human Serum Albumin/interferon alpha2b fusion proteinHuman Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.
Pegasys	Active comparator	Biological: PegasysPegasys 180 mcg, once per week

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human Serum Albumin/interferon alpha2b fusion proteinIn experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.	Biological	Human Serum Albumin/interferon alpha2b
PegasysIn comparator group, each subject will recieve 180mcg once per week.	Biological	Pegasys

Primary outcome

the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
Time frame: 17 weeks
HBV DNA

4 secondary outcomes

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
the recovery rates of ALT after treatment
Time frame: 17 weeks
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
Time frame: 17 weeks
the rates of HBsAg decrease from baseline after treatment
Time frame: 17 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.

Related trials for Hepatitis B Virus

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

meixia wang, professor principal investigator

Beijing YouAn Hospital

jun li, professor principal investigator

The First Affiliated Hospital with Nanjing Medical University

liang chen, professor principal investigator

Shanghai Public Health Clinical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Human Serum Albumin/interferon alpha2b fusion protein and Pegasys in people with Hepatitis B Virus, run by Tianjin SinoBiotech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment (time frame: 17 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.