Trial · NCT07909005
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
NCT07909005, Not yet recruiting, Swedish Orphan Biovitrum
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant. Trials, record NCT07909005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909005
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
- NCT number
- NCT07909005
- Status
- Not yet recruiting
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Swedish Orphan Biovitrum
- Conditions
- Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS), Still Disease
- Interventions
- Local laboratory testing, Local Lab Tests
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Outcome Measure: Incidence rate of treatment-emergent mycobacterium tuberculosis | Timeframe: up to 12 months | Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year |
| Primary | Outcome Measure: Incidence rate of treatment-emergent non-tuberculosis mycobacterium infections | Timeframe: up to 12 months | Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Unit of Measure: Number of events per 100-patient year |
| Primary | Outcome Measure: Incidence rate of treatment-emergent CMV reactivation and/or infection | Timeframe: up to 12 months | Description: Occurrence of treatment-emergent CMV disease including reactivation and/or infection. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year |
| Primary | Outcome Measure: Incidence rate of serious treatment-emergent infections | Timeframe: up to 12 months | Description: Occurrence of serious treatment-emergent infections (including CMV reactivation and/or infection, mycobacterium tuberculosis, and non tuberculosis mycobacterial infections). A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year |
| Secondary | Outcome Measure: Initial Gamifant dose at index | Timeframe: up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: mg/kg |
| Secondary | Outcome Measure: Cumulative Gamifant dose over the index MAS episode | Timeframe: up to 12 months. | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: mg/kg |
| Secondary | Outcome Measure: Duration of Gamifant treatment over the index MAS episode | Timeframe: up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: Days |
| Secondary | Outcome Measure: Gamifant dosing frequency | Timeframe: up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant. Unit of Measure: Number of injections/week |
| Secondary | Outcome Measure: Maximum single Gamifant dose received | Timeframe: up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant. Unit of Measure: mg/kg |
| Secondary | Outcome Measure: Total cumulative Gamifant treatment duration and dose during follow-up. | Timeframe: up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: Months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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/NCT07909005
GET https://conductscience.org/api/trials/v1/NCT07909005/registered