To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Study Details
Study Description
Brief Summary
To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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".
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 40 mg TG-1000 Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
Drug: TG-1000
Capsules taken orally
|
| Experimental: 80 mg TG-1000 Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3. |
Drug: TG-1000
Capsules taken orally
|
| Experimental: 40 mg TG-1000+40 mg TG-1000 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. |
Drug: TG-1000
Capsules taken orally
|
| Placebo Comparator: Placebo Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
Drug: TG-1000
Capsules taken orally
|
Outcome Measures
Primary Outcome Measures
- The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. [Up to Day 9]
The time between the initiation of the study treatment and the first time when the influenza virus RNA cannot be detected.
Secondary Outcome Measures
- Time to alleviation of all influenza symptoms. [Up to Day 9]
The time between the initiation of the study treatment and the alleviation of influenza symptoms.
- The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR). [Up to Day 9]
The percentage of patients positive for virus RNA by RT-PCR.
- The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL). [Up to Day 9]
The change from baseline in the amount of virus RNA.
- Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer. [Up to Day 9]
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).
- The percentage of patients whose symptoms have been alleviated at each time point. [Up to Day 9]
The percentage of patients whose symptoms are alleviated at each time point.
- The percentage of patients reporting normal temperature at each time point. [Up to Day 9]
The percentage of patients whose axillary temperature drops to less than 37ºC after the initiation of the study treatment in the analysis population.
- Time to resolution of fever. [Up to Day 9]
The time between the initiation of the study treatment and the resolution of fever.
- Body temperature at each time point. [Up to Day 9]
Measured axillary temperature.
- Time to return to preinfluenza health status. [Up to Day 9]
Patients will be asked to record their pre-influenza health status between 0 (worst possible health) and 10 (normal health).
- The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire. [Up to Day 9]
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.
- Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia). [Up to Day 9]
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.
- The percentage of patients taking acetaminophen. [Up to Day 9]
The percentage of patients who took acetaminophen.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to provide written informed consent.
-
Age ≥ 18 (or legal adult age) to < 65 years at the time of signing the informed consent.
-
Must have a positive result of Rapid influenza diagnostic test (RIDT) or Polymerase chain reaction (PCR).
-
The time interval between the onset of symptoms and the randomization is 48 hours or less.
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Must be able to comply with all study procedures and assessments, including completion of the patient diary.
Exclusion Criteria:
-
Patients with severe influenza virus infection requiring inpatient treatment.
-
Patients with high risk factors may develop into severe cases.
-
Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.
-
Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.
-
Purulent sputum or purulent tonsillitis.
-
Positive nucleic acid test for COVID-19.
-
Suspects allergic to active ingredients or excipients.
-
Body weight < 40 kg.
-
Has received anti-influenza drug.
-
Has received any investigational agents or devices for any indication within 30 days prior to Screening.
-
Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya Hospital Central South University | Hunan | China |
Sponsors and Collaborators
- TaiGen Biotechnology Co., Ltd.
- R&G Pharma Studies Co.,Ltd.
Investigators
- Principal Investigator: Yan Huang, Xiangya Hospital of Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TG-1000-C-02