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| Name | Class |
|---|---|
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
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To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
This study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the efficacy and safety of different doses of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
Approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio of 1:1:1:1 to receive study treatment orally: "40 mg TG-1000", "80 mg TG-1000", "40mg+40mg TG-1000" or "placebo".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg TG-1000 | Experimental | Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
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| 80 mg TG-1000 | Experimental | Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3. |
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| 40 mg TG-1000+40 mg TG-1000 | Experimental | Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of TG-1000 on Day 3. |
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| Placebo | Placebo Comparator | Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-1000 | Drug | Capsules taken orally |
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| Measure | Description | Time Frame |
|---|---|---|
| The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. | The time between the initiation of the study treatment and the first time when the influenza virus RNA cannot be detected. | Up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to alleviation of all influenza symptoms. | The time between the initiation of the study treatment and the alleviation of influenza symptoms. | Up to Day 9 |
| The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Huang | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Hunan | China |
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A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
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Quadruple
The percentage of patients positive for virus RNA by RT-PCR. |
| Up to Day 9 |
| The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL). | The change from baseline in the amount of virus RNA. | Up to Day 9 |
| Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer. | AUC of the viral load by RT-PCR and AUC of viral titer measured from baseline to Day 9±2 or early termination (Visit 5). | Up to Day 9 |
| The percentage of patients whose symptoms have been alleviated at each time point. | The percentage of patients whose symptoms are alleviated at each time point. | Up to Day 9 |
| The percentage of patients reporting normal temperature at each time point. | The percentage of patients whose axillary temperature drops to less than 37ºC after the initiation of the study treatment in the analysis population. | Up to Day 9 |
| Time to resolution of fever. | The time between the initiation of the study treatment and the resolution of fever. | Up to Day 9 |
| Body temperature at each time point. | Measured axillary temperature. | Up to Day 9 |
| Time to return to preinfluenza health status. | Patients will be asked to record their pre-influenza health status between 0 (worst possible health) and 10 (normal health). | Up to Day 9 |
| The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire. | The VAS score change from baseline of QOL questionnaire.The QOL questionnaire consists 2 sections: the descriptive system and the VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is divided into 5 levels. The VAS records the patient's self-rated health on a 20-cm vertical visual analogue with "the best health the patient can imagine" as 100 and "the worst health the patient can imagine" as 0. | Up to Day 9 |
| Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia). | The percentage of patients in the analysis population who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an AE after the initiation of the study treatment. | Up to Day 9 |
| The percentage of patients taking acetaminophen. | The percentage of patients who took acetaminophen. | Up to Day 9 |