Study to Investigate the Efficacy and Safety of Apomivir®

Launched by FAR EAST BIO-TEC CO., LTD · Aug 30, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Apomivir®, which is designed to help treat seasonal influenza, a type of flu that can make people very sick. Apomivir® is made from a special kind of blue-green algae and has shown promise in earlier studies for fighting various flu viruses. The goal of this phase II study is to see how effective and safe Apomivir® is when given to adults aged 20 to 65 who have flu symptoms.

To participate in the trial, individuals must have a recent diagnosis of influenza and show certain symptoms, like coughing or fatigue, along with a positive flu test. However, there are some important factors that could exclude someone from joining, such as being pregnant, having serious lung conditions, or taking certain medications. If eligible, participants will take Apomivir® twice a day for the study duration and will be monitored for any side effects or improvements in their flu symptoms. This trial is not yet recruiting, but it offers a chance to explore a potential new treatment for flu.

Gender

ALL

Eligibility 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