Trial · NCT04651439
Severe Bullous Drug Eruption and Filgrastim
NCT04651439, Phase 2, Phase 3, Unknown, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Severe Bullous Drug Eruption and Filgrastim. Trials, record NCT04651439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04651439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Severe Bullous Drug Eruption and Filgrastim
- NCT number
- NCT04651439
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 42 participants, estimated
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Rare Diseases, Toxic Epidermal Necrolyses
- Interventions
- Filgrastim, Placebo
- First posted
- 2020-12-03
- Last updated
- 2024-05-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arrest of the SJS/NET progression at day 5 | On day 5 (after 5 injections of ZARZIO or PLACEBO - D0: initiation of treatment) | Comparison between the 2 arms of the proportion of patients with arrest of progression of skin detachment defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Arrest of the SJS/NET progression | At day 3, day 7 and day 15 | Comparison between the 2 arms of the time until the arrest of the SJS/NET progression defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Complete re-epidermization | At day 3, day 5, day 7, day 15 and day 45 | Comparison between the 2 arms of the time until the complete re-epidermization defined by the disappearance of skin rashes and return to normal skin. Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Overall survival | Until 30 days | Comparison between the 2 arms of the overall survival |
| Secondary | Overall survival | Until 1 year | Comparison between the 2 arms of the overall survival |
| Secondary | Duration of hospitalization | 15 days (maximal of SJS/NET episode's hospitalization) | Comparison between the 2 arms of the number days of hospitalization corresponding to the duration of SJS/NET episode's hospitalization. |
| Secondary | Premature discontinuation of experimental treatment | Between day 0 and day 5 | Number of clinical and biological adverse event leading to stop the filgrastim treatment (per patient, nature and grade of the AE (adverse event ) - repository CTCAE version 5.0) |
| Secondary | Adverse events | Until 1 year | Comparison between the 2 arms of the number of clinical and biological adverse event (by organ systems - repository CTCAE version 5.0).. |
| Secondary | Use of systemic corticosteroid therapy | Between day 0 and day 15 | Study of the nature, cumulative doses and indications objectifying a corticosteroid prescription. A comparison between the 2 arms will be done. |
| Secondary | Evaluation of sequels | At day 45, day 60, day 90, day 180 and 1 year | Determination of the proportion of patients with at least one sequel among the following specialty : ophthalmology, stomatology/ORL(otorhinolaryngology), gastroenterology, gynecology, urology and psychiatry, researched during specialized consultations during the remote monitoring phase. A comparison between the 2 arms will be done. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT04651439
GET https://conductscience.org/api/trials/v1/NCT04651439/registered