Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
1 other identifier
interventional
72
1 country
1
Brief Summary
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedNovember 11, 2016
October 1, 2016
7 months
October 27, 2016
November 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
HBsAg(quantitative)
treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
Study Arms (3)
Standard Dose Spirulina Platensis
EXPERIMENTALSpirulina platensis pill/500mg, 3 pills before each meal /6 pills per day
Zero Spirulina Platensis
ACTIVE COMPARATORSpirulina platensis pill/500mg, 6 pills before each meal /12 pills per day
Double Dose Spirulina Platensis
ACTIVE COMPARATORsame as usual, non pill taken
Interventions
As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
the zero pill-taken group is a comparison for two other groups.
As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. Hence, the investigators would like to see if the investigators could improve sero-conversion rates much faster by taking double dose of Spirulina platensis.
Eligibility Criteria
You may qualify if:
- In patients with chronic hepatitis B of taking oral antiviral drugs , and the virus has been detected is less than the amount (HBV DNA \<20 IU / ml), aged between 20 years to 75 years .
You may not qualify if:
- Patients were allergic to seafood.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WanFangH
Tainan, Taiwan
Study Officials
- STUDY DIRECTOR
Ming Shun Wu, Dr
WanFangHospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
November 3, 2016
Study Start
November 1, 2016
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
November 11, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share