Influenza Virus InfectionPhase 2NCT04706468
To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
A Phase 2 study testing TG-1000 in people with Influenza Virus Infection, run by TaiGen Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza Virus Infection
- What is being tested?
- TG-1000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2020to 15 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
Read the 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".
- Conditions
- Influenza Virus Infection
- Being tested
- TG-1000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-1000Drug
Capsules taken orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TG-1000 |
| 80 mg TG-1000 | Experimental | Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3. Receives: Drug: TG-1000 |
| 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. Receives: Drug: TG-1000 |
| Placebo | Placebo comparator | Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. Receives: Drug: TG-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 9
Secondary outcomes (12)
Time to alleviation of all influenza symptoms.
The time between the initiation of the study treatment and the alleviation of influenza symptoms.
Measured: Up to Day 9
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to Day 9
Time to resolution of fever.
The time between the initiation of the study treatment and the resolution of fever.
Measured: Up to Day 9
Body temperature at each time point.
Measured axillary temperature.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to Day 9
The percentage of patients taking acetaminophen.
The percentage of patients who took acetaminophen.
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Dec 2020
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Yan Huang, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706468
- Sponsor's protocol ID
- TG-1000-C-02
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04706468
- Acronym / sponsor ID
- TG-1000-C-02
- Conditions
- Influenza Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
| Arm | Type | Receives |
|---|---|---|
| 40 mg TG-1000 | Experimental | Drug: TG-1000Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
| 80 mg TG-1000 | Experimental | Drug: TG-1000Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3. |
| 40 mg TG-1000+40 mg TG-1000 | Experimental | Drug: TG-1000Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of TG-1000 on Day 3. |
| Placebo | Placebo comparator | Drug: TG-1000Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-1000Capsules taken orally | Drug | 40 mg TG-1000, 40 mg TG-1000+40 mg TG-1000, 80 mg TG-1000, Placebo |
Primary outcome
The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.
Time frame: 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.
12 secondary outcomes
Time to alleviation of all influenza symptoms.
Time frame: Up to Day 9
The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).
Time frame: Up to Day 9
The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).
Time frame: Up to Day 9
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.
Time frame: Up to Day 9
The percentage of patients whose symptoms have been alleviated at each time point.
Time frame: Up to Day 9
The percentage of patients reporting normal temperature at each time point.
Time frame: Up to Day 9
Time to resolution of fever.
Time frame: Up to Day 9
Body temperature at each time point.
Time frame: Up to Day 9
Time to return to preinfluenza health status.
Time frame: Up to Day 9
The visual analog scale (VAS) score change from baseline of quality of life (QOL) questionnaire.
Time frame: Up to Day 9
Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).
Time frame: Up to Day 9
The percentage of patients taking acetaminophen.
Time frame: Up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Huang principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG-1000 in people with Influenza Virus Infection, run by TaiGen Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. (time frame: Up to Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.