Chronic Hepatitis BPhase 1/2NCT01997944
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
A Phase 1/2 study testing Human Serum ALbumin/interferon alpha2a and Pegasys in people with Chronic Hepatitis B, run by Beijing Bio-Fortune Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Human Serum ALbumin/interferon alpha2a and Pegasys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Nov 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Human Serum ALbumin/interferon alpha2a, Pegasys
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Serum ALbumin/interferon alpha2aBiological
600,750 or 900 mcg dosing every 2 weeks
PegasysBiological
180 mcg dosing every week
| Study group | Role | What they receive |
|---|---|---|
| Human Serum Albumin/interferon alpha2a | Experimental | Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C. Receives: Biological: Human Serum ALbumin/interferon alpha2a |
| Pegasys | Active comparator | Peginteferon 180 mcg multiple dose S.C. Receives: Biological: Pegasys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 18 weeks
Secondary outcomes (7)
Decrease of HBV DNA
Measured: 18 weeks
AUCss
Measured: 18 weeks
Css_av
Measured: 18 weeks
Css_min
Measured: 18 weeks
Css-max
Measured: 18 weeks
T1/2
Measured: 18 weeks
Tmax
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Bio-Fortune Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, MD, Principal investigator, Jilin University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997944
- Sponsor's protocol ID
- 921302
- Status last verified
- Nov 2014
- First submitted
- 21 Nov 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT01997944
- Acronym / sponsor ID
- 921302
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Beijing Bio-Fortune Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
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.
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 alpha2a | Experimental | Biological: Human Serum ALbumin/interferon alpha2aHuman Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C. |
| Pegasys | Active comparator | Biological: PegasysPeginteferon 180 mcg multiple dose S.C. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 alpha2a600,750 or 900 mcg dosing every 2 weeks | Biological | Human Serum Albumin/interferon alpha2a |
| Pegasys180 mcg dosing every week | Biological | Pegasys |
Primary outcome
Number of adverse events
Time frame: 18 weeks
7 secondary outcomes
Decrease of HBV DNA
Time frame: 18 weeks
AUCss
Time frame: 18 weeks
Css_av
Time frame: 18 weeks
Css_min
Time frame: 18 weeks
Css-max
Time frame: 18 weeks
T1/2
Time frame: 18 weeks
Tmax
Time frame: 18 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 17 Nov 2014.
Related trials for Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
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.
Junqi Niu, MD principal investigator
Jilin University First Affiliated Hospital
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 alpha2a and Pegasys in people with Chronic Hepatitis B, run by Beijing Bio-Fortune 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 4 inclusion and 9 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 17 Nov 2014. 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?
Number of adverse events (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.