Trial · NCT07909005
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 |
| Secondary | Outcome Measure: Total cumulative Gamifant treatment 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: mg/kg |
| Secondary | Outcome Measure: Reason for gamifant treatment discontinuation | Timeframe: Up to 12 months | Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant. Unit of measure: Participants |
| Secondary | Outcome Measure: Time to MAS resolution | Timeframe: Up to 12 months | Description: Time-to-event analyses assessing the time from the index date to Investigator-assessed MAS resolution. Unit of measure: Days |
| Secondary | Outcome Measure: Number of participants with HLH/MAS-related hospitalizations | Timeframe: Up to 12 months | Description: To describe HLH/MAS-related HCRU during treatment with Gamifant. Unit of measure: Participants |
| Secondary | Outcome Measure: Duration of intensive care unit (ICU) care | Timeframe: Up to 12 months | Description: To describe HLH/MAS-related HCRU during treatment with Gamifant Unit of measure: Days |
| Secondary | Outcome Measure: Duration of hospitalization/length of stay (LoS) | Timeframe: Up to 12 months | Description: To describe HLH/MAS-related HCRU during treatment with Gamifant. Unit of measure: Days |
| Secondary | Outcome Measure: Number of participants with emergency department visits | Timeframe: Up to 12 months | Description: To describe HLH/MAS-related HCRU during treatment with Gamifant Unit of measure: Participants |
| Secondary | Outcome Measure: Number of participants with Prior HLH/MAS-related medications | Timeframe: Up to 12 months | Description: Prior medications are those medications that were started and stopped prior to Gamifant initiation. Unit of measure: Participants |
| Secondary | Outcome Measure: Number of participants with Concomitant HLH/MAS-related medications | Timeframe: Up to 12 months | Description: Concomitant medications are medications that were started prior to or at Gamifant initiation and are ongoing at Gamifant initiation. Unit of measure: Participants |
| Secondary | Outcome Measure: Number of participants with initiation of preemptive antiviral therapy | Timeframe: Up to 12 months | Description: Concomitant medications are medications that were started prior to or at Gamifant initiation and are ongoing at Gamifant initiation. Unit of measure: Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07909005/registered