Trial · NCT06904027
A Clinical Study of Glycerol Phenylbutyrate in Chinese Patients With Urea Cycle Disorders
NCT06904027, Recruiting, Tongji Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study of Glycerol Phenylbutyrate in Chinese Patients With Urea Cycle Disorders. Trials, record NCT06904027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06904027
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study of Glycerol Phenylbutyrate in Chinese Patients With Urea Cycle Disorders
- NCT number
- NCT06904027
- Status
- Recruiting
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Tongji Hospital
- Conditions
- Urea Cycle Disorders
- Interventions
- Glycerol phenylbutyrate Oral Liquid
- First posted
- 2025-04-01
- Last updated
- 2026-04-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean blood ammonia levels at month 3 after enrollment. | months 3 | The average of blood ammonia levels at months 3 after enrollment. |
| Secondary | Mean blood ammonia levels | Baseline, Month 1, Month 6, and every 6 months thereafter (1-5 years) | The average of blood ammonia levels at period of baseline, month 1, month 6, and every 6 months thereafter (1-5 years) |
| Secondary | Maximum blood ammonia levels | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years) | The maximum blood ammonia levels at period of baseline, month 1, month 3, month 6, and every 6 months thereafter (1-5 years) |
| Secondary | Frequency of hyperammonaemic crisis | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years) | The frequency of hyperammonaemic crisis at period of baseline, month 1, month 3, month 6, and every 6 months thereafter (1-5 years) |
| Secondary | Height | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years). | The change of height to the baseline in children aged 0-18 years old, and the proportion of weight in the upper, upper-middle, middle, lower-middle, and lower categories for each age group, according to the growth standards for children under 7 years old (WS/T 423-2022) and standard for height level classification among children and adolescents aged 7\~18 years (WS/T 612-2018）issued by the National Health Commission of the People's Republic of China. |
| Secondary | Weight | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years) | The change of weight to the baseline in children aged 0-7 years old, and the proportion of weight in the upper, upper-middle, middle, lower-middle, and lower categories for each age group, according to the growth standards for children under 7 years old issued by the National Health Commission of the People's Republic of China (WS/T 423-2022). |
| Secondary | Head circumference | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years) | The change of head circumference to the baseline in children aged 0-3 years old, and the proportion of head circumference in the upper, upper-middle, middle, lower-middle, and lower categories for each age group, according to the growth standards for children under 7 years old issued by the National Health Commission of the People's Republic of China (WS/T 423-2022). |
| Secondary | Dose adjustment changes | Baseline, Month 1, Month 3, Month 6, and every 6 months thereafter (1-5 years) | The changes of dose adjustment in glycerol phenylbutyrate throughout the study |
| Secondary | Mean Neonatal Behavioral Neurological Assessment Scores: Behavioral ability, passive muscle tone, active muscle tone, primitive reflexes, and general assessment | Month 6, every year thereafter (1-5 years) | The neonatal behavioral neurological assessment (NBNA) scale was used for newborn participants who were at least 2 months of age, consisting of 20 items, with a maximum score of 40 points. The total scores of the NBNA are derived from the cumulative sum of the scores obtained in behavioral ability (6 items), passive muscle tone (4 items), active muscle tone (4 items), primitive reflexes (3 items), and general assessment (3 items), which are collected according to the scales have been actually completed by the subjects in the clinical practice. The total scores greater than 37 is considered normal, while a score less than or equal to 37 is considered abnormal. |
| Secondary | Mean Bayley Scale of Infant Development Scores: mental scale, motor scale | Month 6, every year thereafter (1-5 years) | The Bayley Scale of Infant Development was used for infant participants whose ages range from 2 months to 30 months, consisting of 244 behavioral items, including 163 items on the mental scale and 81 items on the motor scale. The scores of each infant on the mental and motor scales are converted into standard scores with a mean of 100 and a standard deviation of 16 according to age groups, thereby calculating the Mental Development Index (MDI) and the Psychomotor Development Index (PDI). A total score of MDI and PDI, which are collected according to the scales have been actually completed by the subjects in the clinical practice, are less than 70 indicates developmental delay, 70-79 indicates a borderline state, 80-89 indicates low average, 90-109 indicates average, 110-119 indicates high average, 120-129 indicates superior, and a score of 130 or above indicates very superior. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Digit Span Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06904027
GET https://conductscience.org/api/trials/v1/NCT06904027/registered