RecruitingPhase 3

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections

China322 participantsStarted 2024-03-27

Plain-language 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.

Who can participate

Age range2 Months – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Comply with the following diagnostic criteria:

Exclusion criteria

✕. 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);
✕. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation;
✕. Those who have genetic metabolic diseases;
✕. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
✕. 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;
✕. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.
✕. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;
✕. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;

What they're measuring

Wang bronchiolitis score chanced by percentage from baseline

Timeframe: day 5

Wang bronchiolitis score chanced by percentage from baseline

Timeframe: day 1 to day of last administration (except day 5)

Wang bronchiolitis score of 0 in proportion

Timeframe: day 5

Wang bronchiolitis score total score < 5 points

Timeframe: day 5

Wang bronchiolitis score, the first time the total score reaches < 5 points

Timeframe: day 5

Trial details

NCT IDNCT06363370

SponsorKexing Biopharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Jiajun Xu

86-18851892277 xujiajun@kexing.com

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infections trials

Who can participate

Age range2 Months – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Comply with the following diagnostic criteria:

Exclusion criteria

✕. 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);
✕. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation;
✕. Those who have genetic metabolic diseases;
✕. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
✕. 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;
✕. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.
✕. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;
✕. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;

What they're measuring

Wang bronchiolitis score chanced by percentage from baseline

Timeframe: day 5

Wang bronchiolitis score chanced by percentage from baseline

Timeframe: day 1 to day of last administration (except day 5)

Wang bronchiolitis score of 0 in proportion

Timeframe: day 5

Wang bronchiolitis score total score < 5 points

Timeframe: day 5

Wang bronchiolitis score, the first time the total score reaches < 5 points

Timeframe: day 5