Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06363370
Other study ID # KXZY-GB05-201
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 27, 2024
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source Kexing Biopharm Co., Ltd.
Contact Jiajun Xu
Phone 86-18851892277
Email xujiajun@kexing.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.


Description:

The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 322
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 2 Months to 2 Years
Eligibility Inclusion Criteria: 1. 2 months = age = 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-[(37 weeks-fetal age)/4], gender is not limited; 2. Comply with the following diagnostic criteria: 1) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and/or asthma, lung auspicious pitch and/or wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and/or thick lung texture/slightly/more and/or emphysema and/or the signs of inflammation around the bronchial. 3. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent. Exclusion Criteria: 1. There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the "eczema area and severity index" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen); 2. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation; 3. Those who have genetic metabolic diseases; 4. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen); 5. Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body; 6. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia. 7. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.; 8. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia; 9. Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy; 10. During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease; 11. During the screening, the thoracic effusion, pydion and pus, and pus, etc.; 12. Merce able goose sores suspected mold infection during screening; 13. The laboratory inspection is abnormal during screening:1) White blood cell count>14x109/L (or normal value of normal value) or neutral granulocyte ratio> 70%, and researchers comprehensively judge suspects as merging bacterial infections;2) Excisibility of liver function test: Alanine aminotransferase (ALT) or permine aminamidase (AST)> The upper limit of the normal value is 2 times, or the total biliary erythrin> 1.5 times the upper limit of the normal value;3) Blood routine abnormalities: white blood cell count <3.5X109/L and/or platelet count=100x109/L; 14. Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing; 15. After the history of the history of the disease, the child known (or the mother who is younger than 6 months old) is HIV -positive, or the researcher is highly suspected of being HIV -positive; 16. In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs; 17. Volunteers may not be able to complete this study or researchers who believe that they are not suitable for participating in this clinical trial due to various reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Human interferon a1b Inhalation Solution
Participants will receive Human interferon a1b Inhalation Solution
Inhalation Solution Placebo
Participants will receive Inhalation Solution Placebo

Locations

Country Name City State
China Children's Hospital, Capital Institute of Pediatrics Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Kexing Biopharm Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wang bronchiolitis score chanced by percentage from baseline The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of =9 indicates that the patient is severe. day 5
Primary Wang bronchiolitis score chanced by percentage from baseline The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of =9 indicates that the patient is severe. day 1 to day of last administration (except day 5)
Primary Wang bronchiolitis score of 0 in proportion The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of =9 indicates that the patient is severe. day 5
Primary Wang bronchiolitis score total score < 5 points The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of =9 indicates that the patient is severe. day 5
Primary Wang bronchiolitis score, the first time the total score reaches < 5 points The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of =9 indicates that the patient is severe. day 5
Secondary RSV viral load qPCR test From predose to 120 hours postdose
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Completed NCT04090658 - A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults Phase 1
Completed NCT04231968 - A Study of AK0529 in Chinese Infants Hospitalized With RSV Phase 3
Completed NCT03227029 - Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Terminated NCT02948127 - Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT02873286 - RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults Phase 2
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Withdrawn NCT02864628 - RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults. Phase 1
Completed NCT02247726 - RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. Phase 2
Completed NCT02040831 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02237209 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT01915394 - Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial) N/A
Completed NCT01355016 - A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers Phase 1
Completed NCT00232635 - A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT Phase 2
Completed NCT01155193 - Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Not yet recruiting NCT06083623 - A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Phase 2/Phase 3
Terminated NCT02890381 - Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Active, not recruiting NCT03422237 - Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT03674177 - A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women Phase 1
Completed NCT01968083 - Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1