Chronic Hepatitis BPhase 2NCT02332473
A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B
A Phase 2 study testing Ypeginterferon alfa-2b and Granulocyte-macrophage colony stimulating factor in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 12 sites in China.
Trial summary
This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. 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?
- Ypeginterferon alfa-2b and Granulocyte-macrophage colony stimulating factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 12 sitesChina
- Study dates
- Jun 2014to Aug 2016
- Phase
- Phase 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
- 18yrs≤age≤65yrs.
- 17≤BMI(body mass index)≤28.
- HBsAg positive≥6 months.
- Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
- 2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening.
- Pregnancy test must be negative for female patients of childbearing potential. All patients take effective birth control measures during treatment and 6 months after the treatment.
- Agree to participate in the study and sign the informed consent.
Who cannot join
- Pregnant or lactating females
- Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
- Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
- Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
- Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
- History or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures.
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- Suffering from any other acute or chronic infectious disease.
- Mental disorder or physical disability, or family history of neurological and psychiatric disorders.
- Neutrophil count <1500 cells/mm3, or platelet count <90000 cells/mm3 at screening.
- Child-Pugh≥B, or other evidence of liver decompensation (e.g. serum albumin<35g/L , prothrombin time>3 seconds prolonged, serum bilirubin>2ULN, prothrombin activity <60%, history of liver decompensation).
- Serum creatinine level >ULN in screening period.
- Serum creatine kinase level >2ULN except for physiological factors (e.g., exercise).
- AFP>100ng/L. If 50ng/L<AFP<100ng/L at screening, retest 2 weeks later, and if AFP <50ng/L can enrolled, vs, excluded.
- Hepatocarcinoma or suffering from any other malignant tumor.
- Autoimmune disease(e.g., psoriasis, systemic lupus erythematosus).
- Moderate or severe hypertension, or mild hypertension without well controlled.
- With not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus).
- Drug abusing, or alcoholism.
- HBeAb positive or HBsAb positive at screening.
- Allergic to interferon, or GM-CSF, or any fragment of the study drug.
- Other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hosopital
Beijing, Beijing Municipality
Xiangya Second Hospital, Central-south University
Changsha, Hunan
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian
Nanfang Hospital
Guangzhou, Guangdong
Ruijing Hospital
Shanghai, Shanghai Municipality
Shenyang Sixed People's Hospital
Shenyang, Liaoning
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
Tongji Hospital, Huazhong University of Science & Technology
Wuhan, Hubei
Xijing Hospital
Xi’an, Shanxi
Xiamen Hospital of T.C.M
Xiamen, Fujian
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: A Prospective Phase 2 Clinical Trial to Assess the Efficacy and Safety of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis Patients.
This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.
- Conditions
- Chronic Hepatitis B
- Being tested
- Ypeginterferon alfa-2b, Granulocyte-macrophage colony stimulating factor
- 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.
Ypeginterferon alfa-2bDrug
Also called peginterferon alfa-2b
Granulocyte-macrophage colony stimulating factorDrug
Also called GM-CSF
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Receives: Drug: Ypeginterferon alfa-2b |
| Arm B | Experimental | Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13. Receives: Drug: Ypeginterferon alfa-2b; Drug: Granulocyte-macrophage colony stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of HBeAg seroconversion at the end of treatment
Measured: week 48
Secondary outcomes (5)
Percentage of HBsAg undetectable and seroconversion at the end of treatment
Measured: week 48
Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48
Measured: week 12, 24, 36 and 48
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48
Measured: week 12, 24, 36, and 48
Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48
Measured: treatment week 12, 24, 36, and 48
Percentage of ALT normalization at week 24, 36 and 48
Measured: week 24 ,36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionAug 2016
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.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332473
- Sponsor's protocol ID
- TB1405IFN
- Status last verified
- Aug 2016
- First submitted
- 4 Jan 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase 2 Clinical Trial to Assess the Efficacy and Safety of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis Patients.
- ClinicalTrials.gov ID
- NCT02332473
- Acronym / sponsor ID
- TB1405IFN
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jan 2015 (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 study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Ypeginterferon alfa-2bYpeginterferon alfa-2b,sc. Qw. 48 weeks. |
| Arm B | Experimental | Drug: Ypeginterferon alfa-2b, Drug: Granulocyte-macrophage colony stimulating factorYpeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18yrs≤age≤65yrs.
- 17≤BMI(body mass index)≤28.
- HBsAg positive≥6 months.
- Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
- 2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening.
Key exclusion criteria (21 listed)
- Pregnant or lactating females
- Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
- Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
- Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
- Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Ypeginterferon alfa-2bAlso: peginterferon alfa-2b | Drug | Arm A, Arm B |
| Granulocyte-macrophage colony stimulating factorAlso: GM-CSF | Drug | Arm B |
Primary outcome
Percentage of HBeAg seroconversion at the end of treatment
Time frame: week 48
5 secondary outcomes
Percentage of HBsAg undetectable and seroconversion at the end of treatment
Time frame: week 48
Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48
Time frame: week 12, 24, 36 and 48
Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48
Time frame: week 12, 24, 36, and 48
Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48
Time frame: treatment week 12, 24, 36, and 48
Percentage of ALT normalization at week 24, 36 and 48
Time frame: week 24 ,36 and 48
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 25 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ypeginterferon alfa-2b and Granulocyte-macrophage colony stimulating factor in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 12 sites 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 7 inclusion and 21 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 phase mean?
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?
Percentage of HBeAg seroconversion at the end of treatment (time frame: week 48). 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 25 Jan 2017.