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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents (ZX-7101A-207)

Primary Purpose

Respiratory Viral Infection

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ZX-7101A
Placebo
Sponsored by
Nanjing Zenshine Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Viral Infection focused on measuring adolescent, ZX-7101A

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.≥12 to<18 years of age at the time of randomization, males or females. 2.Patients in the screening period met the following criteria: Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours). At least one of influenza -related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough. 3.The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time; Or at least one systemic or respiratory symptom may occur: a. nasal congestion, b. sore throat, c. cough, d. muscle or joint pain, e. fatigue, f. headache, g. fever. 4.Be able to comply with all the study procedures, complete the subject diary as required(The guardian is allowed to fill in if necessary). 5.The subject and his/her guardian are volunteer to participate in the study and sign the written informed consent form (ICF). 6.The subject agree to maintain abstinence or take reliable contraceptive methods during the trial and persist in until 3 months after the administration of the investigational product. Exclusion Criteria: Patients with severe influenza virus infection requiring inpatient treatment.(Meet any one of the following criteria) (1)Severe cases with one of the following conditions: Persistent high fever for more than 3 days, accompanied by severe cough, purulent sputum, bloody sputum, or chest pain; Fast breathing rate, difficulty breathing, cyanosis of lips; Delayed response, drowsiness, restlessness, and other mental changes or seizures; Severe vomiting, diarrhea, and dehydration symptoms; Concomitant pneumonia; Significant exacerbation of existing underlying diseases; Other clinical situations that require hospitalization. (2)Critical cases with one of the following conditions(Including but not limited to): Respiratory failure; Acute necrotizing encephalopathy; Shock; Multiple organ dysfunction; Other serious clinical situations that require monitoring and treatment. High risk population for severe cases. (Meet any one of the following criteria): (1)Accompanied by the following basic diseases and judged by the investigators to be clinically significant, such as lung diseases, liver diseases, kidney diseases, hematological system diseases, heart diseases, neurological and neuromuscular diseases that affect the ability to clear respiratory secretions, metabolic and endocrine system diseases, etc; (2)Subjects with low immune function, such as malignant tumors, organ or bone marrow transplants, HIV infections, or those who have been taking immunosuppressants for the past 3 months; (3)Clinical significance of correcting QT interval abnormalities in electrocardiogram display; (QTc>440ms in male or QTc>450ms in female); (4)Subjects who require long-term use of drugs containing aspirin or salicylates : It is necessary to take medication containing aspirin or salicylate regularly every day for more than 14 days; (5)BMI exceeds the standards. 3.Bronchitis, pneumonia, pleural effusion or interstitial disease confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening. 4.Subjects who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening. 5.Subjects with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: <13 years of age :white blood cell count (WBC) > 11.3 × 109/L(venous blood);≥13 to<18 years of age :white blood cell count (WBC) > 11.0 × 109/L(venous blood). 6.Subjects with purulent sputum or suppurative tonsillitis. 7.Have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption. 8.Suspected allergic to active ingredients or excipients of the investigational product. 9.Body weight < 20 kg. 10.Medications against influenza virus within 7 days before screening. 11.Have received live vaccines or attenuated live vaccines within 14 days before randomization, influenza vaccines within 6 months before randomization. 12.Suspected or confirmed a history of alcohol or drug abuse.

Sites / Locations

  • Fudan University affiliated Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZX-7101A

Placebo group

Arm Description

40 mg in a single dose

Outcomes

Primary Outcome Measures

The time to the remission of all influenza symptoms (hours)
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild),nd the duration is at least 21.5 hours (approximately 24 hours -10%)

Secondary Outcome Measures

The time influenza RNA turns negative
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
The time Virus Titer turns negative
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Percentage of subjects with RT-PCR positive influenza virus RNA and measurable virus titer at each visit (unit: %)
the number of subjects with RT-PCR positive influenza virus RNA and measurable virus titer /The number of subjects
Time (in hours) for relief of 4 systemic symptoms (muscle or joint pain, weakness, headache, fever, or chills/sweating)
Symptom remission is defined as a score of 0 (asymptomatic) or 1 (mild) for all four of the above symptoms. The duration is at least 21.5 hours (About 24 hours -10%)

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Nanjing Zenshine Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT06099873
Brief Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
Acronym
ZX-7101A-207
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 25, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Zenshine Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.
Detailed Description
In this study, adolescents aged 12 and < 18 with uncomplicated influenza are selected as subjects. Typical systemic and/or respiratory influenza symptoms were required, and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours. This study is divided into screening/treatment period (D1) and observation period (about 2 weeks). You will be eligible before starting study therapy on day 1 (D1). Participants were randomly assigned 1:1 to ZX-7101A group (dose 40 mg, administration once) or placebo group (dose 1 placebo tablet, administration once), with 180 participants planned to be included in each group, for a total of about 360 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Viral Infection
Keywords
adolescent, ZX-7101A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZX-7101A
Arm Type
Experimental
Arm Description
40 mg in a single dose
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZX-7101A
Intervention Description
Day1 Take one tablet of ZX-7101A orally once (specification: 40mg/ tablet) with appropriate amount of warm water
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Day1 Take one tablet of Placebo orally once with appropriate amount of warm water
Primary Outcome Measure Information:
Title
The time to the remission of all influenza symptoms (hours)
Description
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild),nd the duration is at least 21.5 hours (approximately 24 hours -10%)
Time Frame
From accepting ZX-7101A until the 15 days after the first dosing
Secondary Outcome Measure Information:
Title
The time influenza RNA turns negative
Description
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
Time Frame
From accepting ZX-7101A until the 15 days after the first dosing
Title
The time Virus Titer turns negative
Description
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Time Frame
From accepting ZX-7101A until the 15 days after the first dosing
Title
Percentage of subjects with RT-PCR positive influenza virus RNA and measurable virus titer at each visit (unit: %)
Description
the number of subjects with RT-PCR positive influenza virus RNA and measurable virus titer /The number of subjects
Time Frame
From accepting ZX-7101A until the 15 days after the first dosing
Title
Time (in hours) for relief of 4 systemic symptoms (muscle or joint pain, weakness, headache, fever, or chills/sweating)
Description
Symptom remission is defined as a score of 0 (asymptomatic) or 1 (mild) for all four of the above symptoms. The duration is at least 21.5 hours (About 24 hours -10%)
Time Frame
From accepting ZX-7101A until the 15 days after the first dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.≥12 to<18 years of age at the time of randomization, males or females. 2.Patients in the screening period met the following criteria: Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours). At least one of influenza -related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough. 3.The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time; Or at least one systemic or respiratory symptom may occur: a. nasal congestion, b. sore throat, c. cough, d. muscle or joint pain, e. fatigue, f. headache, g. fever. 4.Be able to comply with all the study procedures, complete the subject diary as required(The guardian is allowed to fill in if necessary). 5.The subject and his/her guardian are volunteer to participate in the study and sign the written informed consent form (ICF). 6.The subject agree to maintain abstinence or take reliable contraceptive methods during the trial and persist in until 3 months after the administration of the investigational product. Exclusion Criteria: Patients with severe influenza virus infection requiring inpatient treatment.(Meet any one of the following criteria) (1)Severe cases with one of the following conditions: Persistent high fever for more than 3 days, accompanied by severe cough, purulent sputum, bloody sputum, or chest pain; Fast breathing rate, difficulty breathing, cyanosis of lips; Delayed response, drowsiness, restlessness, and other mental changes or seizures; Severe vomiting, diarrhea, and dehydration symptoms; Concomitant pneumonia; Significant exacerbation of existing underlying diseases; Other clinical situations that require hospitalization. (2)Critical cases with one of the following conditions(Including but not limited to): Respiratory failure; Acute necrotizing encephalopathy; Shock; Multiple organ dysfunction; Other serious clinical situations that require monitoring and treatment. High risk population for severe cases. (Meet any one of the following criteria): (1)Accompanied by the following basic diseases and judged by the investigators to be clinically significant, such as lung diseases, liver diseases, kidney diseases, hematological system diseases, heart diseases, neurological and neuromuscular diseases that affect the ability to clear respiratory secretions, metabolic and endocrine system diseases, etc; (2)Subjects with low immune function, such as malignant tumors, organ or bone marrow transplants, HIV infections, or those who have been taking immunosuppressants for the past 3 months; (3)Clinical significance of correcting QT interval abnormalities in electrocardiogram display; (QTc>440ms in male or QTc>450ms in female); (4)Subjects who require long-term use of drugs containing aspirin or salicylates : It is necessary to take medication containing aspirin or salicylate regularly every day for more than 14 days; (5)BMI exceeds the standards. 3.Bronchitis, pneumonia, pleural effusion or interstitial disease confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening. 4.Subjects who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening. 5.Subjects with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: <13 years of age :white blood cell count (WBC) > 11.3 × 109/L(venous blood);≥13 to<18 years of age :white blood cell count (WBC) > 11.0 × 109/L(venous blood). 6.Subjects with purulent sputum or suppurative tonsillitis. 7.Have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption. 8.Suspected allergic to active ingredients or excipients of the investigational product. 9.Body weight < 20 kg. 10.Medications against influenza virus within 7 days before screening. 11.Have received live vaccines or attenuated live vaccines within 14 days before randomization, influenza vaccines within 6 months before randomization. 12.Suspected or confirmed a history of alcohol or drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Wenhong, Doctor
Phone
13816357098
Email
zhangwenhong202208@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Zhimin, Doctor
Phone
13958096916
Email
13958096916@163.com
Facility Information:
Facility Name
Fudan University affiliated Huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents

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