Apomivir®_Influenza
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Purpose
The purpose of this study is to evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.) and the time to resolution of influenza symptoms defined as all flu symptom scores ≤ 1 after initiation of study treatment.
| 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, Multi-center Study of Apomivir® in the Treatment of Influenza Infection |
- 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:
- Change in laboratory data
- Adverse events
- 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 Subject who is withdrawn prior to the resolution of influenza symptom is censored at the last known time point.
- Change in virus titer. [ Time Frame: Day 3, 6, 15 and 29 ] [ Designated as safety issue: No ]To evaluate the change in virus titer assessed by real-time RT-PCR15.
- Time to bring down a fever. [ Time Frame: from day 1 to day 29, depends on the time to sympton resolution of individual subjects. ] [ Designated as safety issue: No ]Time to bring down a fever (oral temperature < 38˚C)
- Time to achieve afebrile [ Time Frame: from day 1 to day 29, depends on the time to sympton resolution of individual subjects. ] [ Designated as safety issue: No ]Time to achieve afebrile (oral temperature < 37.2˚C)
- Time to alleviation of daily interference [ Time Frame: from day 1 to day 29, depends on the time to sympton resolution of individual subjects. ] [ Designated as safety issue: No ]Time to alleviation of daily interference (all interference scores ≤ 1)
- 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 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 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | April 2014 (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)
|
Detailed Description:
This is a prospective, randomized, double-blind, 2-arm, parallel, multi-center study. Approximately 196 patients with fever defined as body temperature ≥ 38˚C, and at least one respiratory symptom and one other constitutional symptom will be invited into this study to target 156 evaluable patients. A nasopharyngeal/throat swabs rapid test for influenza A and B will be conducted and only patients 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/tab) will be provided on enrollment for rescue use. 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). The 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).
At baseline, real-time RT-PCR and viral culture will be conducted for checking eligibility. In the following visits, real-time RT-PCR will be performed to measure 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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Females and males aged between 20 and 65
Presumptive diagnosis of influenza based on the following clinical characteristics:
oFever defined as oral temperature ≥ 38˚C
oPresence of 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
oPositive for influenza A or B (nasopharyngeal/throat swab - rapid test)
- Able and willing to comply with the study procedure and give written informed consent
Exclusion Criteria:
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
- Patient with chronic pulmonary diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease, or critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- Patient with a history of non-febrile convulsions, neuromuscular disorders or cognitive dysfunction that may compromise respiratory secretions, or who are currently receiving anticonvulsive agents
- Patient with uncontrolled diabetes mellitus, uncontrolled hypertension, or unstable cardiac disease such as angina pectoris, myocardial infarction, arrhythmia and congestive heart failure, etc.
- Patient with a history of sickle cell anemia and other hemoglobinopathies
- Patient with active systemic infection (for which the systemic treatment is required) or known HIV positive
- Patient with immuno-compromised medical conditions or who are currently receiving immunosuppressive therapy
- Patient with malignancies, except in situ of the cervix or adequately treated basal cell or squamous cell skin carcinoma, within the 5 years
- Patient who is morbidly obese (Body Mass Index (BMI) ≥ 40)
- Patient with 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 at screening
- Known hypersensitivity to any ingredients in Apomivir® or other blue agar
- Patients with disease (such rheumatoid arthritis or Kawasaki disease) who requiring long-term (defined as > 14 days) use of aspirin (except dose ≤ 100 mg/day) therapy within 6 months prior to screening
- Use of daily supplement(s) containing blue agar within 1 month prior to screening
- Use of any investigational product within 1 month prior to screening
- Known or suspected as alcoholism or drug addiction within 1 year prior to screening
- Any 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
Contacts and Locations| Contact: YI-HSIANG CHEN | +886-2-2655-8198 | mrx1025@hotmail.com |
| 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. | |
| 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: | August 30, 2012 |
| 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 June 17, 2013