Trial · NCT03866954
Trial of Erythrocyte Encapsulated Thymidine Phosphorylase In Mitochondrial Neurogastrointestinal Encephalomyopathy
NCT03866954, Phase 2, Withdrawn, St George's, University of London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Erythrocyte Encapsulated Thymidine Phosphorylase In Mitochondrial Neurogastrointestinal Encephalomyopathy. Trials, record NCT03866954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03866954
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Erythrocyte Encapsulated Thymidine Phosphorylase In Mitochondrial Neurogastrointestinal Encephalomyopathy
- NCT number
- NCT03866954
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- St George's, University of London
- Conditions
- Mitochondrial Diseases, Metabolic Disease, Inborn Errors of Metabolism
- Interventions
- EE-TP
- First posted
- 2019-03-07
- Last updated
- 2023-10-11
- Other registries' IDs
- eudract:2018-003000-39
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The safety of EE-TP as measured by the incidence, frequency, and severity of treatment emergent adverse events | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Incidence, frequency, and severity of adverse events will be summarised by dose level, maximum severity, and , Medical Dictionary for Regulatory Activities system organ class, and preferred term. The intensity/severity will be graded by Common terminology criteria for adverse events (CTCAE) criteria, including relation to treatment (IMP and/or infusion). |
| Primary | The safety of EE-TP as measured by the incidence of laboratory abnormalities, based on haematology, serum biochemistry, and urinalysis test | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Incidence of laboratory abnormalities outside the clinical reference ranges based on haematology, serum biochemistry, and urinalysis test |
| Primary | The safety of EE-TP as measured by the vital sign measurements systolic and diastolic blood pressure | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Systolic and diastolic blood pressure measured in units of millimeters of mercury (mmHg) will be recorded. Measurements outside the clinical reference ranges will be summarised by dose level, together with changes from baseline. |
| Primary | The safety of EE-TP as measured by the vital sign measurement heart rate | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Heart rate measured as beats per minute (BPM) will be recorded. Measurements outside the clinical reference ranges will be summarised by dose level, together with changes from baseline. |
| Primary | The safety of EE-TP as measured by the vital sign measurement respiratory rate | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Respiratory rate measured as number of breaths taken per minute will be recorded. Measurements outside the clinical reference ranges will be summarised by dose level, together with changes from baseline. |
| Primary | The safety of EE-TP as measured by the vital sign measurement body temperature | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | Body temperature measured in degrees Celsius will be recorded. Measurements outside the clinical reference ranges will be summarised by dose level, together with changes from baseline. |
| Primary | The safety of EE-TP as measured by 12 lead ECG parameters | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | 12 lead ECG parameter data (QTc, QTcB, QTcF, the PR and QT intervals, QRS duration, and heart rate) outside the clinical reference ranges will be summarised by dose level. |
| Primary | The safety of EE-TP as measured by the use of concomitant medication(s) | Day -120 to Follow-up visit (90 days post-final dose) at 31 months | The use of concomitant medication(s) will be listed |
| Primary | The assessment of pharmacodynamic effects of EE-TP by the measurement of plasma thymidine and deoxyuridine concentrations | Plasma and urine metabolites: Day -120 to Follow-up visit at 31 months | Changes from baseline in plasma concentrations of thymidine and deoxyuridine will be calculated using Day 0 or Day 1 as the baseline. |
| Primary | The assessment of pharmacodynamic effects of EE-TP by the measurement of urine thymidine and deoxyuridine concentrations | Plasma and urine metabolites: Day -120 to Follow-up visit at 31 months; antibodies Day -1 to follow-up visit at 31 months | Changes from baseline in urine concentrations of thymidine and deoxyuridine will be calculated using Day 0 or Day 1 as the baseline. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 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.
Papers4
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/NCT03866954
GET https://conductscience.org/api/trials/v1/NCT03866954/registered?page=2