1.
ClinicalTrials.gov; 09/07/2023; TrialID: NCT05948020
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05948020
ABSTRACT
Condition:
PhenylketonuriaIntervention:
Biological: CBT102-A capsule;Other: Placebo capsulePrimary outcome:
Changes from Baseline in Blood Phe ConcentrationCriteria:
Inclusion Criteria:
- Blood phe = 600µmol/L at newborn screening;
- Blood phe = 600µmol/L at least 3 times in the last 1 year before screening, and the
blood Phe = 600µmol/L in the last 1 time;
- Screening laboratory evaluations (e.g., chemistry panel, complete blood count,
urinalysis, creatinine clearance, CRP) within normal limits or judged to be not
clinically significant by the investigator;
- Stable diet for at least 60 days prior to screening;
- Able to produce at least 2 bowel movements per week on average without using any form
of laxatives;
- Adolescents and children's guardians can voluntarily complete the whole process of
informed consent, including stool, urine and blood collection, adherence to diet
control, hospital monitoring, follow-up and oral trial drug compliance, and sign
informed consent.
Exclusion Criteria:
- The standard percentile values of height and weight of Chinese children aged 0 to 18
years were evaluated with weight less than P3 or weight greater than P97;
- History of active or chronic passage of 3 or more loose stools per day;
- Have any medical conditions or medications that may affect the absorption of
medications or nutrients;
- History of or current immunodeficiency disorder including autoimmune disorders;
- Subjects with obvious influenza-like symptoms caused by COVID-19 or other viral
infections during screening;
- Hepatitis B surface antigen and/or hepatitis C antibodies and/or treponema pallidum
antibodies positive;
- Subjects who are dependent on drugs and alcohol;
- Received gene therapy related to PKU;
- Intolerant or allergic to Escherichia coli Nissle 1917 (EcN);
- Active gastrointestinal bleeding or a proven history of gastrointestinal bleeding
within 60 days prior to screening;
- Antibiotics within 28 days before the planned first dose of investigational product
(IP), or anticipated during the study period;
- Take probiotic supplements within 28 days before the planned first dose of IP, or
anticipated during the study period;
- A history of fever, confirmed bacteremia, or other active infection within 30 days
prior to the planned first dose of IP;
- Drugs that use of the digestive system has been used within 30 days prior to the
planned first dose of IP;
- Drugs that may affect gastrointestinal function has been used within 30 days prior to
the planned first dose of IP;
- Major survery performed within 90 days before the anticipated first dose of IP or
planned surgery or hospitalization during the study period;
- Take sapropterin (KUVAN®) within 1 week before the planned first dose of IP;
- Use pegylated recombinant phenylalanine ammonia lyase (PALYNZIQ™) within 30 days
before the planned first dose of IP;
- History of severe immune adverse reactions to PALYZIQ;
- Participated in an interventional clinical trial and used the investigational drug
within 60 days or 5 half-lives before the planned first dose of IP;
- Subjects who may not be able to complete the study for other reasons.
2.
ClinicalTrials.gov; 18/05/2022; TrialID: NCT05381363
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05381363
ABSTRACT
Condition:
COVID-19;ChildrenIntervention:
Drug: Inhaled Interferon a2b;Other: Standard of CarePrimary outcome:
Days requiring isolation (DRI)Criteria:
Inclusion Criteria:
- Patients diagnosed as mild to moderate COVID-19 infection with positive PCR test and
symptoms (Ct < 35)
- Parents and patients comprehend and welling to participate in this study.
- Agree to the collection of nasal swabs per day as protocol.
Exclusion Criteria:
- Patients evaluated as severe or critically severe type of COVID-19 infection
(Individuals who have SpO2 <94% on room air, oxygen treatment is necessary,
respiratory failure, septic shock, and/or multiple organ dysfunction).
- Patients with comorbidities
- Decline to participate by parents or children
- Allergy to any study medication or usage of any kind of interferon treatment within 14
days before test
- Children cannot tolerate the inhalation treatment
- Any situation where the program cannot be carried out safely.
3.
ClinicalTrials.gov; 30/03/2022; TrialID: NCT05351216
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05351216
ABSTRACT
Condition:
Kaposiform HemangioendotheliomaPrimary outcome:
Titers of Hepatitis B virus surface antibody;Titers of Hepatitis B virus surface antibody;Titers of Hepatitis B virus surface antibody;Titers of Hepatitis B virus surface antibodyCriteria:
Inclusion Criteria:
- Case groups:
- KHE patients treated with sirolimus.
- After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and
assessment, those participants will be vaccinated with live attenuated vaccines or
inactivated vaccines in a timely order according to the advice.
- Control groups:
- Healthy children with no immune deficiencies.
- Participants are vaccinated according to the National Immunization Program in a timely
manner.
- Participants are matched to the case group according to age.
Exclusion Criteria:
- HBsAg, HBeAg positive, or other active infectious diseases;
- History of immunodeficiency or low immunoglobulin levels;
- Autoimmune disease or fever during blood collection;
- Use of other medication or surgery;
- Suffering from other bleeding disorders;
- Suffering from other solid tumors or hematological tumors, etc.;
- Withdraw informed consent.
4.
ChiCTR; 2020-05-28; TrialID: ChiCTR2000033342
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2000033342
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
Case series:Treated with variate traditional Chinese medicines;Primary outcome:
Body temperature;Respiratory syndrome;Pulmonary imaging;Nucleic acid testing;Criteria:
Inclusion criteria: (1) Pediatric patients diagnosed with COVID-19;(2) Treated with heat-clearing and detoxifying traditional Chinese medicines.
Exclusion criteria: (1) Loss of efficacy and safety indices;
(2) the time measuring evaluation indices does not align with the time taking medicines
5.
ClinicalTrials.gov; 18/02/2020; TrialID: NCT04279899
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04279899
ABSTRACT
Condition:
Perinatal Problems;Infectious Disease;Neonatal InfectionPrimary outcome:
The death of newborns with COVID-19;The SARS-CoV-2 infection of neonates born to mothers with COVID-19Criteria:
Inclusion Criteria:
- The neonates with COVID-19,or neonates born by infected mothers
Exclusion Criteria:
- The neonates with major anomalies
6.
ChiCTR; 2020-02-14; TrialID: ChiCTR2000029814
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2000029814
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;Primary outcome:
Time fo fever reduction;Time of nucleic acid negative;Severe conversion rate;Improvement time of respiratory symptoms;Criteria:
Inclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results.Exclusion criteria: No exclusion criteria
7.
ITMCTR; 2020-02-14; TrialID: ITMCTR2000003013
Clinical Trial Register
| ICTRP | ID: ictrp-ITMCTR2000003013
ABSTRACT
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
experimental group:Integrated Traditional Chinese and Western Medicine;control group:Western Medicine;Primary outcome:
Time of nucleic acid negative;Severe conversion rate;Time fo fever reduction;Improvement time of respiratory symptoms;Criteria:
Inclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results.Exclusion criteria: No exclusion criteria