<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01677689</url>
  </required_header>
  <id_info>
    <org_study_id>QCR09032</org_study_id>
    <nct_id>NCT01677689</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Efficacy and Safety of Apomivir®</brief_title>
  <official_title>A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far East Bio-Tec Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far East Bio-Tec Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue&#xD;
      cyanobacterium with patented freeze-thaw lysis and extraction method. According to the&#xD;
      preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral&#xD;
      ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause&#xD;
      illness, paralysis and even death, especially in children and elderly people. This phase II&#xD;
      study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in&#xD;
      subjects with seasonal influenza.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center&#xD;
      study. Approximately 196 subjects with fever defined as body temperature &gt;= 38˚C, with at&#xD;
      least one respiratory symptom and one other constitutional symptom will be invited into this&#xD;
      study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for&#xD;
      influenza A and B will be conducted and only subjects with positive results could be&#xD;
      recruited. All eligible subjects will be randomized to one of the following treatment group&#xD;
      in a 1:1 ratio.&#xD;
&#xD;
      Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1&#xD;
      capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at&#xD;
      enrollment. All flu symptom relief agents could be used only for rescue use of persistent&#xD;
      fever or flu symptoms (&gt;= 24 hours). A digital thermometer and diary card will be dispensed&#xD;
      at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and&#xD;
      daily record regarding the severity of their influenza symptoms and the level of interference&#xD;
      on daily activity. The monitoring frequency will be twice daily (after drug administration)&#xD;
      from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as&#xD;
      remission of all flu symptoms and interferences). Treatment failure is defined as secondary&#xD;
      illnesses, antibiotic use and hospitalization due to disease progression.&#xD;
&#xD;
      For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For&#xD;
      subjects who are not completely cured before Day 15 (Visit 4), further therapy will be&#xD;
      conducted and they should return on Day 29; for those who are completely cured, only a&#xD;
      telephone follow-up will be conducted on Day 29.&#xD;
&#xD;
      The severity of fever will be scored using a 4-point scale:&#xD;
&#xD;
      0 = &lt; 37.2°C&#xD;
&#xD;
        1. = &gt;= 37.2 to &lt; 38.0°C&#xD;
&#xD;
        2. = &gt;= 38.0 to &lt; 39.0°C&#xD;
&#xD;
        3. = &gt;= 39.0 °C&#xD;
&#xD;
      Other influenza symptoms (such as cough, nasal obstruction, sore throat, fatigue, headache&#xD;
      and myalgias) will also be assessed using a 4-point scale:&#xD;
&#xD;
      0 = none,&#xD;
&#xD;
        1. = mild,&#xD;
&#xD;
        2. = moderate,&#xD;
&#xD;
        3. = severe&#xD;
&#xD;
      The level of interference on daily activities (including running, lifting heavy objects,&#xD;
      participating in strenuous sports, moderate activities), such as moving a table, pushing a&#xD;
      vacuum cleaner, bowling, or playing golf, lifting or carrying groceries, climbing several&#xD;
      flights of stairs, climbing one flight of stairs, bending, kneeling, or stooping, walking&#xD;
      more than a mile, walking several blocks, walking one blocks, and bathing or dressing&#xD;
      yourself, will be assessed according to a 3-point scale&#xD;
&#xD;
      0 = no, no limited&#xD;
&#xD;
        1. = yes, limited a little&#xD;
&#xD;
        2. = yes, limited a lot&#xD;
&#xD;
      Confirmatory tests for infective virus strain, real-time RT-PCR and viral culture will be&#xD;
      conducted at baseline. In the following study visits, real-time RT-PCR will be performed to&#xD;
      measure the influenza viral load/titer in nasopharyngeal/throat swabs specimen. For those who&#xD;
      have been completely cured prior to Day 15, the real-time RT-PCR assessment could be omitted&#xD;
      on Day 29. All subjects enrolled will be followed until the end of study, but only subjects&#xD;
      with influenza PCR or viral culture positive could be evaluable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2018</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).</measure>
    <time_frame>from day1 to day 29, the entire treatment period and follow-up period.</time_frame>
    <description>Safety endpoints:&#xD;
Change in laboratory data&#xD;
Adverse events&#xD;
Serious adverse events (SAE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.</measure>
    <time_frame>from day 1 to day 29, depends on the time to sympton resolution of individual subjects.</time_frame>
    <description>The time to resolution of influenza symptom is defined as the duration from the study drug initiation to all flu symptom scores ≤ 1. Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in virus titer.</measure>
    <time_frame>Day 3, 6 compared to baseline (Day 1)</time_frame>
    <description>To evaluate the change in virus titer assessed by real-time RT-PCR15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve afebrile</measure>
    <time_frame>after initiation of study treatment</time_frame>
    <description>Time to bring down a fever (oral temperature &lt; 37.2˚C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of influenza symptom score during study period</measure>
    <time_frame>twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured</time_frame>
    <description>All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of interference on daily activity and time to alleviation of the interference during study period</measure>
    <time_frame>twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured</time_frame>
    <description>All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of rescue medication used for fever or influenza symptoms during study period</measure>
    <time_frame>twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured</time_frame>
    <description>All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion and time to treatment failure during study period</measure>
    <time_frame>from day 1 to day 29, including treatment period and follow-up period</time_frame>
    <description>Proportion and time to treatment failure (including secondary illnesses, antibiotic use and hospitalization due to disease progression) during study period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apomivir®</intervention_name>
    <description>Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>FE-L-APO(drug substance)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Main inclusion criteria:&#xD;
&#xD;
          1. Females and males aged between 20 and 65&#xD;
&#xD;
          2. Presumptive diagnosis of influenza based on the following clinical characteristics:&#xD;
&#xD;
               -  Present at least one respiratory symptom (e.g. cough, nasal obstruction, sore&#xD;
                  throat) and at least one constitutional symptom other than fever (e.g. fatigue,&#xD;
                  headache, myalgias) of less than 48-hour duration&#xD;
&#xD;
               -  Positive for influenza A or B (nasopharyngeal/throat swab - rapid test)&#xD;
&#xD;
          3. Able and willing to comply with the study procedure and give written informed consent&#xD;
&#xD;
        2. Main exclusion criteria:&#xD;
&#xD;
          1. Female who is pregnant/lactating or planning to be pregnant, or female of childbearing&#xD;
             potential* who is not using medically recognized method of contraception&#xD;
&#xD;
             * Other than those who have been surgically sterilized (defined as having undergone&#xD;
             hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation&#xD;
             alone is not considered sufficient) or one year post-menopausal&#xD;
&#xD;
          2. Subject with chronic pulmonary diseases or critical condition or already developed&#xD;
             severe respiratory distress with hypoxaemia on presentation&#xD;
&#xD;
          3. Subject with a history of non-febrile convulsions, neuromuscular disorders or&#xD;
             cognitive dysfunction that may compromise respiratory secretions, or who are currently&#xD;
             receiving anticonvulsive agents&#xD;
&#xD;
          4. Subject with clinically important illness, malignancies, systemic infection, other&#xD;
             medical or psychiatric condition which places the subject at unacceptable risk to&#xD;
             participate in the study or confounds the ability to interpret data from the study&#xD;
&#xD;
          5. Subject with significant abnormal laboratory findings (hemoglobin level &lt; 9.0 g/dL,&#xD;
             WBC &lt; 4000/mm3, platelet count &lt; 100,000/mm3, ALT or AST &gt; 2.5 x upper limit of normal&#xD;
             (ULN), or estimated creatinine clearance &lt; 30 mL/min within 4 weeks prior to baseline)&#xD;
&#xD;
          6. Subject who are currently receiving immunosuppressive therapy,&#xD;
&#xD;
          7. Subject has taken daily supplement(s) containing blue agar within 1 month prior to&#xD;
             screening, or any other medication that may affect the study results&#xD;
&#xD;
          8. Known hypersensitivity to any ingredients in Apomivir® or other blue agar&#xD;
&#xD;
          9. Use of any investigational product within 1 month prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Wen Hang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YI-HSIANG CHEN</last_name>
    <role>Study Director</role>
    <affiliation>Far East Bio-Tec Co., Ltd</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>YI-HSIANG CHEN</last_name>
    <phone>+886-2-2655-8198</phone>
    <email>mrx1025@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Der-Yang Cho, M.D.</last_name>
      <phone>+886-4-22052121</phone>
      <email>answer@mail.cmuh.org.tw</email>
    </contact>
    <investigator>
      <last_name>Liang-Wen Hang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://www.febico.com.tw</url>
    <description>The drug substance of the IP is the same with a marked nutrition supplement. And this is the official product page of the marked nutrition supplement.</description>
  </link>
  <reference>
    <citation>Lynch G, Low L, Li S, Sloane A, Adams S, Parish C, Kemp B, Cunningham AL. Sulfated polyanions prevent HIV infection of lymphocytes by disruption of the CD4-gp120 interaction, but do not inhibit monocyte infection. J Leukoc Biol. 1994 Sep;56(3):266-72. doi: 10.1002/jlb.56.3.266.</citation>
    <PMID>7521897</PMID>
  </reference>
  <reference>
    <citation>Shih CM, Cheng SN, Wong CS, Kuo YL, Chou TC. Antiinflammatory and antihyperalgesic activity of C-phycocyanin. Anesth Analg. 2009 Apr;108(4):1303-10. doi: 10.1213/ane.0b013e318193e919.</citation>
    <PMID>19299804</PMID>
  </reference>
  <reference>
    <citation>Gonzalez R, Rodriguez S, Romay C, Ancheta O, Gonzalez A, Armesto J, Remirez D, Merino N. Anti-inflammatory activity of phycocyanin extract in acetic acid-induced colitis in rats. Pharmacol Res. 1999 Jan;39(1):55-9.</citation>
    <PMID>10366332</PMID>
  </reference>
  <reference>
    <citation>Shih SR, Tsai KN, Li YS, Chueh CC, Chan EC. Inhibition of enterovirus 71-induced apoptosis by allophycocyanin isolated from a blue-green alga Spirulina platensis. J Med Virol. 2003 May;70(1):119-25. doi: 10.1002/jmv.10363.</citation>
    <PMID>12629652</PMID>
  </reference>
  <reference>
    <citation>Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF. Epub 2007 Oct 17.</citation>
    <PMID>17942826</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oral temperature</keyword>
  <keyword>respiratory symptom</keyword>
  <keyword>cough</keyword>
  <keyword>nasal obstruction</keyword>
  <keyword>sore throat</keyword>
  <keyword>fever</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01677689
org study id: QCR09032
nct id: NCT01677689
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue
      cyanobacterium with patented freeze-thaw lysis and extraction method. According to the
      preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral
      ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause
      illness, paralysis and even death, especially in children and elderly people. This phase II
      study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in
      subjects with seasonal influenza.
This is a prospective, randomized, double-blind, parallel, placebo-controlled, multi-center
      study. Approximately 196 subjects with fever defined as body temperature >= 38˚C, with at
      least one respiratory symptom and one other constitutional symptom will be invited into this
      study to target 156 evaluable subjects. A nasopharyngeal/throat swabs rapid test for
      influenza A and B will be conducted and only subjects with positive results could be
      recruited. All eligible subjects will be randomized to one of the following treatment group
      in a 1:1 ratio.

      Study Group: Apomivir® 1 capsule (120 mg/cap) twice daily for 5 days Control Group: Placebo 1
      capsule twice daily for 5 days A pack of acetaminophen (500 mg) will be provided at
      enrollment. All flu symptom relief agents could be used only for rescue use of persistent
      fever or flu symptoms (>= 24 hours). A digital thermometer and diary card will be dispensed
      at baseline (Day 1). Subjects will be instructed to complete the body temperature record, and
      daily record regarding the severity of their influenza symptoms and the level of interference
      on daily activity. The monitoring frequency will be twice daily (after drug administration)
      from Day 1 to Day 5, and cut down to once daily until Day 29 or completed cure (defined as
      remission of all flu symptoms and interferences). Treatment failure is defined as secondary
      illnesses, antibiotic use and hospitalization due to disease progression.

      For safety and efficacy assessments, all subjects should return on Day 3, 6 and 15. For
      subjects who are not completely cured before Day 15 (Visit 4), further therapy will be
      conducted and they should return on Day 29; for those who are completely cured, only a
      telephone follow-up will be conducted on Day 29.

      The severity of fever will be scored using a 4-point scale:

      0 = < 37.2°C

        1. = >= 37.2 to < 38.0°C

        2. = >= 38.0 to < 39.0°C

        3. = >= 39.0 °C

      Other influenza symptoms (such as cough, nasal obstruction, sore throat, fatigue, headache
      and myalgias) will also be assessed using a 4-point scale:

      0 = none,

        1. = mild,

        2. = moderate,

        3. = severe

      The level of interference on daily activities (including running, lifting heavy objects,
      participating in strenuous sports, moderate activities), such as moving a table, pushing a
      vacuum cleaner, bowling, or playing golf, lifting or carrying groceries, climbing several
      flights of stairs, climbing one flight of stairs, bending, kneeling, or stooping, walking
      more than a mile, walking several blocks, walking one blocks, and bathing or dressing
      yourself, will be assessed according to a 3-point scale

      0 = no, no limited

        1. = yes, limited a little

        2. = yes, limited a lot

      Confirmatory tests for infective virus strain, real-time RT-PCR and viral culture will be
      conducted at baseline. In the following study visits, real-time RT-PCR will be performed to
      measure the influenza viral load/titer in nasopharyngeal/throat swabs specimen. For those who
      have been completely cured prior to Day 15, the real-time RT-PCR assessment could be omitted
      on Day 29. All subjects enrolled will be followed until the end of study, but only subjects
      with influenza PCR or viral culture positive could be evaluable population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.).
time frame: from day1 to day 29, the entire treatment period and follow-up period.
description: Safety endpoints:
Change in laboratory data
Adverse events
Serious adverse events (SAE)
measure: To evaluate the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
time frame: from day 1 to day 29, depends on the time to sympton resolution of individual subjects.
description: The time to resolution of influenza symptom is defined as the duration from the study drug initiation to all flu symptom scores ≤ 1. Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
measure: Change in virus titer.
time frame: Day 3, 6 compared to baseline (Day 1)
description: To evaluate the change in virus titer assessed by real-time RT-PCR15.
measure: Time to achieve afebrile
time frame: after initiation of study treatment
description: Time to bring down a fever (oral temperature < 37.2˚C)
measure: Severity of influenza symptom score during study period
time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
description: All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
measure: Level of interference on daily activity and time to alleviation of the interference during study period
time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
description: All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
measure: Proportion of rescue medication used for fever or influenza symptoms during study period
time frame: twice daily from Day 1 to Day 6 and once daily until Day 29 or completely cured
description: All subjects should complete the diary card twice daily from Day 1 to Day 6 and cut down to once daily until Day 29 or completely cured.
measure: Proportion and time to treatment failure during study period
time frame: from day 1 to day 29, including treatment period and follow-up period
description: Proportion and time to treatment failure (including secondary illnesses, antibiotic use and hospitalization due to disease progression) during study period
arm group label: Control Group
arm group type: Placebo Comparator
description: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal
arm group label: Study Group
arm group type: Experimental
description: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
intervention type: Drug
intervention name: Apomivir®
description: Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
arm group label: Study Group
other name: FE-L-APO(drug substance)
intervention type: Drug
intervention name: Placebo
description: Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
arm group label: Control Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Liang-Wen Hang, MD
role: Principal Investigator
affiliation: China Medical University Hospital
last name: YI-HSIANG CHEN
role: Study Director
affiliation: Far East Bio-Tec Co., Ltd
last name: YI-HSIANG CHEN
phone: +886-2-2655-8198
email: mrx1025@hotmail.com
facility: 
contact: 
investigator: 
country: Taiwan
url: http://www.febico.com.tw
description: The drug substance of the IP is the same with a marked nutrition supplement. And this is the official product page of the marked nutrition supplement.
citation: Lynch G, Low L, Li S, Sloane A, Adams S, Parish C, Kemp B, Cunningham AL. Sulfated polyanions prevent HIV infection of lymphocytes by disruption of the CD4-gp120 interaction, but do not inhibit monocyte infection. J Leukoc Biol. 1994 Sep;56(3):266-72. doi: 10.1002/jlb.56.3.266.
PMID: 7521897
citation: Shih CM, Cheng SN, Wong CS, Kuo YL, Chou TC. Antiinflammatory and antihyperalgesic activity of C-phycocyanin. Anesth Analg. 2009 Apr;108(4):1303-10. doi: 10.1213/ane.0b013e318193e919.
PMID: 19299804
citation: Gonzalez R, Rodriguez S, Romay C, Ancheta O, Gonzalez A, Armesto J, Remirez D, Merino N. Anti-inflammatory activity of phycocyanin extract in acetic acid-induced colitis in rats. Pharmacol Res. 1999 Jan;39(1):55-9.
PMID: 10366332
citation: Shih SR, Tsai KN, Li YS, Chueh CC, Chan EC. Inhibition of enterovirus 71-induced apoptosis by allophycocyanin isolated from a blue-green alga Spirulina platensis. J Med Virol. 2003 May;70(1):119-25. doi: 10.1002/jmv.10363.
PMID: 12629652
citation: Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF. Epub 2007 Oct 17.
PMID: 17942826
responsible party type: Sponsor
mesh term: Influenza, Human