Study to Investigate the Efficacy and Safety of Apomivir®

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Far East Bio-Tec Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Far East Bio-Tec Co., Ltd
ClinicalTrials.gov Identifier:
NCT01677689
First received: August 30, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: Apomivir®
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Far East Bio-Tec Co., Ltd:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    Safety endpoints:

    1. Change in laboratory data
    2. Adverse events
    3. Serious adverse events (SAE)

  • 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. ] [ Designated as safety issue: No ]
    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 Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.


Secondary Outcome Measures:
  • Change in virus titer. [ Time Frame: Day 3, 6 compared to baseline (Day 1) ] [ Designated as safety issue: No ]
    To evaluate the change in virus titer assessed by real-time RT-PCR15.

  • Time to achieve afebrile [ Time Frame: after initiation of study treatment ] [ Designated as safety issue: No ]
    Time to bring down a fever (oral temperature < 37.2˚C)

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Proportion and time to treatment failure during study period [ Time Frame: from day 1 to day 29, including treatment period and follow-up period ] [ Designated as safety issue: No ]
    Proportion and time to treatment failure (including secondary illnesses, antibiotic use and hospitalization due to disease progression) during study period


Estimated Enrollment: 196
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal
Drug: Placebo
Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Experimental: Study Group
Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Drug: Apomivir®
Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
Other Name: FE-L-APO(drug substance)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

1. Main inclusion criteria:

  1. Females and males aged between 20 and 65
  2. Presumptive diagnosis of influenza based on the following clinical characteristics:

    • Present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
    • Positive for influenza A or B (nasopharyngeal/throat swab - rapid test)
  3. Able and willing to comply with the study procedure and give written informed consent

2. Main exclusion criteria:

  1. Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception

    * Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal

  2. Subject with chronic pulmonary diseases or critical condition or already developed severe respiratory distress with hypoxaemia on presentation
  3. Subject with a history of non-febrile convulsions, neuromuscular disorders or cognitive dysfunction that may compromise respiratory secretions, or who are currently receiving anticonvulsive agents
  4. Subject with clinically important illness, malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
  5. Subject with significant abnormal laboratory findings (hemoglobin level < 9.0 g/dL, WBC < 4000/mm3, platelet count < 100,000/mm3, ALT or AST > 2.5 x upper limit of normal (ULN), or estimated creatinine clearance < 30 mL/min within 4 weeks prior to baseline)
  6. Subject who are currently receiving immunosuppressive therapy,
  7. Subject has taken daily supplement(s) containing blue agar within 1 month prior to screening, or any other medication that may affect the study results
  8. Known hypersensitivity to any ingredients in Apomivir® or other blue agar
  9. Use of any investigational product within 1 month prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677689

Contacts
Contact: YI-HSIANG CHEN +886-2-2655-8198 mrx1025@hotmail.com

Locations
Taiwan
China Medical University Hospital Not yet recruiting
Taichung City, Taiwan, 40447
Contact: Der-Yang Cho, M.D.    +886-4-22052121    answer@mail.cmuh.org.tw   
Principal Investigator: Liang-Wen Hang, M.D.         
Sponsors and Collaborators
Far East Bio-Tec Co., Ltd
Investigators
Principal Investigator: Liang-Wen Hang, MD China Medical University Hospital
Study Director: YI-HSIANG CHEN Far East Bio-Tec Co., Ltd
  More Information

Additional Information:
Publications:
Responsible Party: Far East Bio-Tec Co., Ltd
ClinicalTrials.gov Identifier: NCT01677689     History of Changes
Other Study ID Numbers: QCR09032
Study First Received: August 30, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Far East Bio-Tec Co., Ltd:
oral temperature
respiratory symptom
cough
nasal obstruction
sore throat
fever

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014