A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a multicenter, randomized, open-label, parallel-controlled, prospective clinical study. It aims to evaluate the efficacy and safety of aerosolized Peginterferon α-2b injection in the treatment of pediatric respiratory syncytial virus pneumonia. The overall study is divided into a screening period, a treatment period, and a follow-up period. Eligible children with respiratory syncytial virus pneumonia will be randomly assigned to the experimental group 1, experimental group 2, and the control group at a ratio of 1:1:1.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: f
View:

• (1)Age: 1 year ≤ age ≤ 3 years; (2) Gender: Both male and female participants are eligible; (3) According to the 9th edition of Zhu Fute's Practical Pediatrics, meet the following diagnostic criteria: a. RSV test positive; b. Clinical manifestations: Fever, cough, wheezing; c. Physical signs: Rapid breathing and moist rales in the lungs; (4) Time: The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (starting from the occurrence of any symptom such as fever, cough, or wheezing); (5) Informed consent: The legal guardian of the child understands and signs the informed consent form (if the legal guardians are the parents, both parents need to sign together).

Locations
Other Locations
China
Chengdu Women's and Children's Central Hospital
RECRUITING
Chengdu
West China Second University Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Lina Chen, Ph.D
chenln66@163.com
028-88570522
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 90
Treatments
Experimental: Peginterferon α-2b 45 mcg dose group
Experimental: Peginterferon α-2b 90 mcg dose group
Other: Control group
Sponsors
Leads: West China Second University Hospital

This content was sourced from clinicaltrials.gov