Trial · NCT02733367
Extension Study for Patients Entered Into Study Infacort 003
NCT02733367, Phase 3, Completed, Neurocrine UK Limited; results first posted 2019-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study for Patients Entered Into Study Infacort 003. Trials, record NCT02733367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02733367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study for Patients Entered Into Study Infacort 003
- NCT number
- NCT02733367
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Adrenal Insufficiency
- Interventions
- Infacort®
- First posted
- 2016-04-11
- Last updated
- 2026-10-02
- Results first posted
- 2019-09-13
- Limitations and caveats
- This study was designed as a safety study to evaluate the long-term use of Infacort in routine clinical practice. Efficacy results should be viewed as exploratory and interpreted with care.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | 29 months | The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit. |
| Secondary | Growth Velocity | 29 months | Growth velocity standard deviation score (SDS). Body height/length (cm) was obtained at each visit by specially trained paediatric endocrine nurses or physicians using standard calibrated auxological methods. |
| Secondary | Cortisol Levels | 29 months | Cortisol levels measured from dried blood spots. The dried blood spots were analysed for multi-steroids, including cortisol (all subjects). Blood spot absolute laboratory values for the safety population are presented. A dried blood spot sample was collected at the initial and final visits, every month for the first 2 months of the study and thereafter every 6 months (unless required after 3 months). |
| Secondary | Number of Participants Exhibiting a Change in Tanner Development Stage | 29 months | The Tanner Development Stage was assessed as an additional analysis in this study. All assessments (breast, genitalia, and pubic hair) were Grade 1 (pre-pubertal) at baseline, with only 1 subject (in Cohort 2) showing a change during the study. Subject 018 showed progression to Grade 2 in the pubic hair category (sparse, pigmented hair mainly on labia). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | 29 months | adverse events | NUMBER | |
| SECONDARY | Growth Velocity | 29 months | Reference data for growth velocity is only available for patients \<=6 years old at time of assessment. Therefore n=2 \& not 4 for C1 at Month 11. Subject 001 was re-enrolled so no Visit 10 data available and, therefore, n=1 for C1 at Month 23. | Standard Deviation Score | MEAN |
| SECONDARY | Cortisol Levels | 29 months | The reason why n=14 at Visit 1 is because of no result for Subjects 005, 010, 017 \& 018. N=12 at Final Visit due to 12 completers. | nmol/L | MEAN |
| SECONDARY | Number of Participants Exhibiting a Change in Tanner Development Stage | 29 months | 'Count of Participants' data below represents the number of subjects that exhibited a change from baseline in their Tanner Development Stage. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Infacort | Treatment-Emergent Adverse Events (TEAE) - Overall | 193 | adverse events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Infacort | Serious TEAEs | 9 | adverse events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Infacort | Severe TEAEs | 0 | adverse events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Infacort | Moderate TEAEs | 42 | adverse events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Infacort | Mild TEAEs | 151 | adverse events | |
| Growth Velocity | Infacort | visit 6 - 11th Month | 0.6343 | Standard Deviation 2.51996 | Standard Deviation Score |
| Growth Velocity | Infacort | Visit 10 - 23rd Month | 0.9214 | Standard Deviation 1.88757 | Standard Deviation Score |
| Cortisol Levels | Infacort | Visit 1 | 43.329 | Standard Deviation 48.3217 | nmol/L |
| Cortisol Levels | Infacort | Final Visit | 22.022 | Standard Deviation 27.1323 | nmol/L |
| Number of Participants Exhibiting a Change in Tanner Development Stage | Infacort | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infacort | 18 | |
| Overall Study | COMPLETED | Infacort | 12 | |
| Overall Study | NOT COMPLETED | Infacort | 6 |
Source ClinicalTrials.gov
Adverse events55
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 | Secondary hypertension | Vascular disorders | Infacort | 1 | 18 | 1 |
| other | Laceration | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Thermal burn | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Tooth injury | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Venomous sting | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Injury | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Scar | Injury, poisoning and procedural complications | Infacort | 1 | 18 | 1 |
| other | Genitourinary operation | Surgical and medical procedures | Infacort | 2 | 18 | 2 |
| other | Circumcision | Surgical and medical procedures | Infacort | 1 | 18 | 1 |
| other | Body temperature increased | Investigations | Infacort | 2 | 18 | 6 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infacort | 0 | 18 |
| Total, other adverse events | Infacort | 14 | 18 |
| Total, serious adverse events | Infacort | 3 | 18 |
Source ClinicalTrials.gov
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.
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/NCT02733367
GET https://conductscience.org/api/trials/v1/NCT02733367/events?page=2