Trial · NCT01390077
Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria
NCT01390077, Phase 2, Phase 3, Completed, University of California, San Diego; results first posted 2021-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria. Trials, record NCT01390077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390077
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria
- NCT number
- NCT01390077
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Alkaptonuria
- Interventions
- Nitisinone
- First posted
- 2011-07-08
- Last updated
- 2021-04-22
- Results first posted
- 2021-04-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Homogentisic Acid Excretion | 3-6 months | Urine homogentisic acid (umol/mmol creatinine) |
| Secondary | Tyrosine Levels | 3-6 months | Plasma tyrosine (uM) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Homogentisic Acid Excretion | 3-6 months | uM | MEAN | |
| SECONDARY | Tyrosine Levels | 3-6 months | uM | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Homogentisic Acid Excretion | HGA, Baseline | 1425.9 | Standard Deviation 678.3 | uM | |
| Homogentisic Acid Excretion | HGA, 2 mg/d Nitisinone | 113.1 | Standard Deviation 70.9 | uM | |
| Homogentisic Acid Excretion | HGA, 4 mg Nitisinone | 34.0 | Standard Deviation 12.9 | uM | |
| Tyrosine Levels | Tyrosine, Baseline | 53.1 | Standard Deviation 14.8 | uM | |
| Tyrosine Levels | Tyrosine, 2 mg/d Nitisinone | 668.7 | Standard Deviation 114.7 | uM | |
| Tyrosine Levels | Tyrosine, 4 mg Nitisinone | 703.7 | Standard Deviation 120.8 | uM |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitisinone | 8 | |
| Overall Study | Treatment | Nitisinone | 7 | |
| Overall Study | COMPLETED | Nitisinone | 7 | |
| Overall Study | NOT COMPLETED | Nitisinone | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ocular irritation | Eye disorders | Nitisinone | 2 | 7 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Nitisinone | 1 | 7 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nitisinone | 0 | 7 |
| Total, other adverse events | Nitisinone | 3 | 7 |
| Total, serious adverse events | Nitisinone | 0 | 7 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01390077
GET https://conductscience.org/api/trials/v1/NCT01390077/registered