HBeAg Positive Chronic Hepatitis BPhase 4NCT02412319
The Clinical Trial of the Anti Hepatitis B Placenta Transfer Factor Injection
A Phase 4 study testing Anti-HBV placenta transfer factor injection in people with HBeAg Positive Chronic Hepatitis B, run by Shineway Pharmaceutical Co.,Ltd.
Trial summary
Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBeAg Positive Chronic Hepatitis B
- What is being tested?
- Anti-HBV placenta transfer factor injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2017
- Phase
- Phase 4
- 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
- aged 18-65, sex not limited;
- patients with HBeAg positive chronic hepatitis B: Screening HBsAg positive for more than 6 months; screening HBeAg positive; screening serum HBV DNA≥1.0×105U/ml；
- 2 * ULN (2 times the upper limit of normal value) < ALT <10 * ULN (10 times the upper limit of normal value);;
- total bilirubin <51μmol/L;
- hepatitis B virus resistance gene sequencing negative;
- agree in the process of the study, do not participate in any other clinical studies or other anti HBV therapy;
- before the beginning of the study, understand and sign the informed consent form approved by the ethics committee, and cooperate to conduct clinical research according to the requirements for the study.
Who cannot join
- by the following evidences prompt suspected hepatocellular carcinoma: B ultrasound or imaging examination discover occupying lesion;B ultrasound normal but serum alpha fetoprotein (AFP) level has a continuous increasing trend; AFP > 100ng/ml, and after review, still so.
- with liver disease acute exacerbation cause a transient liver function decompensation disease or baseline with clinical performance of decompensated liver disease;
- serum creatinine ≥1.5mg/dl (≥130μmol/l);
- the serum amylase > 2 times the normal reference upper limit value;
- hemoglobin (male <100g/L, female <90g/L), white blood cell< 3.5* 109/L, platelet< 60 * 109/L;
- combined with infection of HCV (anti -HCV positive), HIV, anti -HAV IgM positive, anti -HDV IgM positive, anti -HEV IgM positive, anti -EBV IgM positive, anti -CMV IgM positive, autoimmune hepatitis(such as the titer of anti nuclear antibody> 1:160) or activite liver disease caused by other known or unknown reason;
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- investigators consider that may interfere with the treatment,evaluation or compliance of the subjects, including any uncontrolled clinical significance of kidneys, heart, lungs, blood vessels, neurogenic, digestive system, metabolic diseases (diabetes, hyperthyroidism, adrenal disease), immune function disorder or tumor;
- subjects with a history of alcoholism or drug abuse,investigators consider the subjects cannot comply with this protocol or affect the results analysis;
- pregnancy,lactation or female subjects plan to conceive or the companions of male subjects plan to conceive during the study
- 6 months before the study medication used immunosuppressants,immunomodulators(thymosin alpha), cytotoxic drugs;
- 6 months before the study medication used anti HBV drug therapy (interferon, Lamivudine, Adefovir, Entecavir and Telbivudine, Tenofovir,etc);
- plan or have had liver transplantation;
- received other study drug treatment within 3 months prior to screening;
- drug allergy history or allergic for Nucleoside or Nucleotide drug;
- the subjects non compliance with the protocol or subjects exist any situation which investigators considered not suitable for participation in this study.
About this study
Official title: The Efficacy and Safety of the Anti Hepatitis B Placenta Transfer Factor Injection in the Treatment of HBeAg Positive Chronic Hepatitis B, Randomized, Double Blind, Placebo Controlled, Multi Center Clinical Trial
Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.
Read the detailed description
This study using entecavir tablets as basic therapy, is a randomized, double-blind, placebo-controlled multi center study, including the screening period (-4 weeks), baseline and treatment period (96 weeks). The treatment period of first 48 weeks, using entecavir tablets as basic treatment, placebo-controlled trials; the second 48 weeks, taking entecavir tablets alone, continue observation experiment.
- Conditions
- HBeAg Positive Chronic Hepatitis B
- Being tested
- Anti-HBV placenta transfer factor injection, Placebo
- Keywords
- HBeAg positive chronic hepatitis B, HBeAg serum conversion rate, HBeAg serum disappearance rate, HBeAg and HBsAg titer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HBV placenta transfer factor injectionDrug
Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
PlaceboOther
Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks Receives: Drug: Anti-HBV placenta transfer factor injection |
| Comparator Group | Placebo comparator | Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg serum conversion rate
The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment
Measured: Week 48
Secondary outcomes (11)
HBeAg serum conversion rate
The HBeAg serum conversion rate of the Test Group and the Control Group for treatment week 24, week 72
Measured: Week 24, 72
HBeAg disappearance rate
The HBeAg disappearance rate of the Test Group and the Control Group for treatment week 24, week 48 and week 72
Measured: Week 24, 48 and 72
HBV DNA titer
The proportion of subjects for each observation point in HBV DNA titer decreased 2 logarithmic
Measured: Week-4, 0,12,24,48,72 and 96
The proportion of subjects for the HBV DNA can not be detected
The proportion of subjects for the HBV DNA can not be detected in treatment week 24, week 48 and week 72
Measured: Week 24, 48 and 72
HBeAg and HBsAg titer
The changes of HBeAg and HBsAg titer at each observation point
Measured: Week-4, 0,12,24,48,72 and 96
The quantitative changes of anti -HBc
The quantitative changes of anti -HBc in each observation point
Measured: Week-4, 0,12,24,48,72 and 96
The variation of ALT
The variation of ALT in each observation point
Measured: Week-4,24,48,72 and 96
The seroconversion rate of HBsAb and HBeAb
The seroconversion rate of HBsAb and HBeAb in each observation point
Measured: Week-4, 0,12,24,48,72 and 96
The resistance mutation rate of HBsAb and HBeAb
The resistance mutation ncidence of HBsAb and HBeAb in each observation point
Measured: Week-4, 0,12,24,48,72 and 96
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb in each observation point
Measured: Week-4, 0,12,24,48,72 and 96
The changes of relative immune parameters of the transfer factor in peripheral blood(the number of T lymphocytes and the expression levels of cytokines)
The changes of relative immune parameters of the transfer factor in peripheral blood
Measured: Week 0, 12, 24, 48, 72, 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBeAg Positive 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shineway Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guiqiang Wang, Doctor, Study chair, Peking University First HospitalMaorong Wang, Doctor, Principal investigator, China People's Liberation Army No. Eight One HospitalZheling Wang, Doctor, Principal investigator, Qingdao Infectious Diseases HospitalZhiqiang zou, Doctor, Principal investigator, Yantai Infectious Diseases HospitalPeili Zhao, Doctor, Principal investigator, The Third Hospital of Qinhuangdao CityDexing Jia, Doctor, Principal investigator, Weifang People's HospitalZhenghua Zhao, Doctor, Principal investigator, Taian City Central HospitalFeng Gao, Doctor, Principal investigator, Linyi People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412319
- Sponsor's protocol ID
- SW002
- Status last verified
- Apr 2015
- First submitted
- 10 Mar 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Anti Hepatitis B Placenta Transfer Factor Injection in the Treatment of HBeAg Positive Chronic Hepatitis B, Randomized, Double Blind, Placebo Controlled, Multi Center Clinical Trial
- ClinicalTrials.gov ID
- NCT02412319
- Acronym / sponsor ID
- SW002
- Conditions
- HBeAg Positive Chronic Hepatitis B
- Keywords
- HBeAg positive chronic hepatitis B, HBeAg serum conversion rate, HBeAg serum disappearance rate, HBeAg and HBsAg titer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Shineway Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Apr 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.
Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.
Detailed description
This study using entecavir tablets as basic therapy, is a randomized, double-blind, placebo-controlled multi center study, including the screening period (-4 weeks), baseline and treatment period (96 weeks). The treatment period of first 48 weeks, using entecavir tablets as basic treatment, placebo-controlled trials; the second 48 weeks, taking entecavir tablets alone, continue observation experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Anti-HBV placenta transfer factor injectionAnti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks |
| Comparator Group | Placebo comparator | Other: PlaceboPhysiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18-65, sex not limited;
- patients with HBeAg positive chronic hepatitis B: Screening HBsAg positive for more than 6 months; screening HBeAg positive; screening serum HBV DNA≥1.0×105U/ml；
- 2 * ULN (2 times the upper limit of normal value) < ALT <10 * ULN (10 times the upper limit of normal value);;
- total bilirubin <51μmol/L;
- hepatitis B virus resistance gene sequencing negative;
Key exclusion criteria (15 listed)
- by the following evidences prompt suspected hepatocellular carcinoma: B ultrasound or imaging examination discover occupying lesion;B ultrasound normal but serum alpha fetoprotein (AFP) level has a continuous increasing trend; AFP > 100ng/ml, and after review, still so.
- with liver disease acute exacerbation cause a transient liver function decompensation disease or baseline with clinical performance of decompensated liver disease;
- serum creatinine ≥1.5mg/dl (≥130μmol/l);
- the serum amylase > 2 times the normal reference upper limit value;
- hemoglobin (male <100g/L, female <90g/L), white blood cell< 3.5* 109/L, platelet< 60 * 109/L;
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 |
|---|---|---|
| Anti-HBV placenta transfer factor injectionAnti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks | Drug | Experimental Group |
| PlaceboPhysiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks | Other | Comparator Group |
Primary outcome
HBeAg serum conversion rate
Time frame: Week 48
The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment
11 secondary outcomes
HBeAg serum conversion rate
Time frame: Week 24, 72
HBeAg disappearance rate
Time frame: Week 24, 48 and 72
HBV DNA titer
Time frame: Week-4, 0,12,24,48,72 and 96
The proportion of subjects for the HBV DNA can not be detected
Time frame: Week 24, 48 and 72
HBeAg and HBsAg titer
Time frame: Week-4, 0,12,24,48,72 and 96
The quantitative changes of anti -HBc
Time frame: Week-4, 0,12,24,48,72 and 96
The variation of ALT
Time frame: Week-4,24,48,72 and 96
The seroconversion rate of HBsAb and HBeAb
Time frame: Week-4, 0,12,24,48,72 and 96
The resistance mutation rate of HBsAb and HBeAb
Time frame: Week-4, 0,12,24,48,72 and 96
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb
Time frame: Week-4, 0,12,24,48,72 and 96
The changes of relative immune parameters of the transfer factor in peripheral blood(the number of T lymphocytes and the expression levels of cytokines)
Time frame: Week 0, 12, 24, 48, 72, 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
Guiqiang Wang, Doctor study chair
Peking University First Hospital
Maorong Wang, Doctor principal investigator
China People's Liberation Army No. Eight One Hospital
Zheling Wang, Doctor principal investigator
Qingdao Infectious Diseases Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-HBV placenta transfer factor injection in people with HBeAg Positive Chronic Hepatitis B, run by Shineway Pharmaceutical Co.,Ltd.
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 15 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
HBeAg serum conversion rate (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 9 Apr 2015.