Back to resultsTo Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Primary Purpose
Influenza Virus Infection
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TG-1000
Sponsored by
About this trial
This is an interventional treatment trial for Influenza Virus Infection
Eligibility 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.
- 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.
Sites / Locations
- Xiangya Hospital Central South University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
40 mg TG-1000
80 mg TG-1000
40 mg TG-1000+40 mg TG-1000
Placebo
Arm Description
Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.
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.
Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to alleviation of all influenza symptoms.
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).
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).
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.
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.
The percentage of patients whose symptoms are alleviated at each time point.
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.
Time to resolution of fever.
The time between the initiation of the study treatment and the resolution of fever.
Body temperature at each time point.
Measured axillary temperature.
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).
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.
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.
The percentage of patients taking acetaminophen.
The percentage of patients who took acetaminophen.
Full Information
NCT ID
NCT04706468
First Posted
January 6, 2021
Last Updated
March 8, 2022
Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
R&G Pharma Studies Co.,Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04706468
Brief Title
To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
R&G Pharma Studies Co.,Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 mg TG-1000
Arm Type
Experimental
Arm Description
Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
Arm Title
80 mg TG-1000
Arm Type
Experimental
Arm Description
Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.
Arm Title
40 mg TG-1000+40 mg TG-1000
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.
Intervention Type
Drug
Intervention Name(s)
TG-1000
Intervention Description
Capsules taken orally
Primary Outcome Measure Information:
Title
The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
Description
The time between the initiation of the study treatment and the first time when the influenza virus RNA cannot be detected.
Time Frame
Up to Day 9
Secondary Outcome Measure Information:
Title
Time to alleviation of all influenza symptoms.
Description
The time between the initiation of the study treatment and the alleviation of influenza symptoms.
Time Frame
Up to Day 9
Title
The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).
Description
The percentage of patients positive for virus RNA by RT-PCR.
Time Frame
Up to Day 9
Title
The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).
Description
The change from baseline in the amount of virus RNA.
Time Frame
Up to Day 9
Title
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.
Description
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).
Time Frame
Up to Day 9
Title
The percentage of patients whose symptoms have been alleviated at each time point.
Description
The percentage of patients whose symptoms are alleviated at each time point.
Time Frame
Up to Day 9
Title
The percentage of patients reporting normal temperature at each time point.
Description
The percentage of patients whose axillary temperature drops to less than 37ºC after the initiation of the study treatment in the analysis population.
Time Frame
Up to Day 9
Title
Time to resolution of fever.
Description
The time between the initiation of the study treatment and the resolution of fever.
Time Frame
Up to Day 9
Title
Body temperature at each time point.
Description
Measured axillary temperature.
Time Frame
Up to Day 9
Title
Time to return to preinfluenza health status.
Description
Patients will be asked to record their pre-influenza health status between 0 (worst possible health) and 10 (normal health).
Time Frame
Up to Day 9
Title
The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire.
Description
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.
Time Frame
Up to Day 9
Title
Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).
Description
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.
Time Frame
Up to Day 9
Title
The percentage of patients taking acetaminophen.
Description
The percentage of patients who took acetaminophen.
Time Frame
Up to Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Huang
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Hunan
Country
China
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
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