Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Virus Infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

Time to alleviation of all influenza symptoms.
Up to Day 9
The percentage of patients have positive for virus RNA by real time polymerase chain reaction(RT-PCR).
Up to Day 9
The change from baseline in virus RNA by RT-PCR (unit: log₁₀ virus particles/mL).
Up to Day 9
Area Under the Concentration (AUC) of virus RNA by RT-PCR and AUC of virus titer.
Up to Day 9
The percentage of patients whose symptoms have been alleviated at each time point.
Up to Day 9
+7 more secondary outcomes

Study Arms (4)

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.

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.

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.

Interventions

TG-1000Drug

Capsules taken orally

40 mg TG-100040 mg TG-1000+40 mg TG-100080 mg TG-1000Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

R&G Pharma Studies Co.,Ltd.
Industrycollaborator
TaiGen Biotechnology Co., Ltd.
Industrylead

Study Sites (1)

Xiangya Hospital Central South University

Hunan, China

Study Officials

Yan Huang
Xiangya Hospital of Central South University
PRINCIPAL INVESTIGATOR

Enrollment

202 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Quadruple
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 12, 2021

Study Start

December 15, 2020

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

40 mg TG-1000

80 mg TG-1000

40 mg TG-1000+40 mg TG-1000

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

40 mg TG-1000

80 mg TG-1000

40 mg TG-1000+40 mg TG-1000

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations