Trial · NCT05628558
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Influence of different hot spot variants of the F8 gene responsible for hemophilia on the factor VIII pharmacokinetics after desmopressin infusion | Through study completion, an average of 1 year | Genotyping of the F8 gene were all performed for the diagnosis of hemophilia A, so before patients inclusion in the study. They were realized with Sanger method. F8 variants will be presented according to the HGVS nomenclature and compared to the international EAHAD-F8 database. Mutations considered as hot spot mutations if they are carried by at least 5 enrolled patients. All the hot spot F8 variants will be compared to all the primary outcome measures described below. |
| Primary | Post-DDAVP peak factor VIII (FVIII) levels | Through study completion, an average of 1 year | Factor VIII levels were all measured with a chronometric one stage-assay, just before and after the DDAVP infusion (30 min and 1 hour). |
| Primary | Post-DDAVP recoveries of factor VIII (FVIII) levels | Through study completion, an average of 1 year | Factor VIII levels were all measured with a chronometric one stage-assay, just before and after the DDAVP infusion (30 min and 1 hour). Recoveries of FVIII = peak FVIII (post-DDAVP) / basal FVIII (pre-DDAVP) |
| Primary | Post-DDAVP factor VIII (FVIII) half-lives | Through study completion, an average of 1 year | Factor VIII levels (in IU/mL) were all measured with a chronometric one stage-assay. Half lives (in hours) will be caclulated following the formula : C=C0\*e(-Ke.t) where C, C0, Ke and t denote respectively, the post-DDAVP FVIII, peak FVIII, the elimination rate constant, and time after DDAVP administration. FVIII half-lives = Ln(2)/Ke. |
| Primary | Post-DDAVP factor VIII (FVIII) area under the curve (AUC) | Through study completion, an average of 1 year | Factor VIII levels (in IU/mL) were all measured with a chronometric one stage-assay, just before and after the DDAVP infusion (30 min and 1 hour). Half lives will be caclulated following the formula : C=C0\*e(-Ke.t) where C, C0, Ke and t denote respectively, the post-DDAVP FVIII, peak FVIII, the elimination rate constant, and time after DDAVP administration. AUC (in h.IU/mL) will be determined with a trapezoidal method. |
| Primary | Absolute response of FVIII to DDAVP | Through study completion, an average of 1 year | Absolute response is related to the height of the FVIII peak (in IU/mL). This score comprise 3 groups : * Null when peak FVIII \<0.3 IU/mL * Partial when 0.3 IU/mL≤ peak FVIII \<0.5 IU/mL * Complete when peak FVIII ≥0.5 IU/mL |
| Primary | Relative response of FVIII to DDAVP | Through study completion, an average of 1 year | Relative response is related to the height of the FVIII recovery. This score comprise 3 groups : * Null when FVIII recovery \<2 * Partial when 2≤ FVIII recovery \<3 * Complete when FVIII recovery ≥3 |
| Primary | Absolute duration of FVIII to DDAVP | Through study completion, an average of 1 year | The absolute duration determines the time (in hours) that the FVIII level is maintained ≥0.5 IU/mL after the FVIII peak. This score comprise 3 groups : * Short/null when duration \<3 hours * Medium when 3h≤ duration ≤6 hours * Complete when time \>6 hours |
| Primary | Relative duration of FVIII to DDAVP | Through study completion, an average of 1 year | The absolute duration is related to the FVIII half life after DDAVP. This score comprise 3 groups : * Short/null when FVIII half life \<3 hours * Medium when 3 hours\< FVIII half life \<5 hours * Complete when FVIII half life ≥6 hours |
| Secondary | Influence of the von Willebrand factor on the factor VIII pharmacokinetics after the desmopressin infusion | Through study completion, an average of 1 year | Von Willebrand factors levels (in IU/mL) were all measured as antigenic values with immunologic method before and after DDAVP until 24h post-infusion. Von Willebrand factor levels will be compared to primary outcome measures from 2 to 9. This analysis will be performed at the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2. |
| Secondary | Influence of age on the factor VIII pharmacokinetics after the desmopressin infusion | Through study completion, an average of 1 year | Ages (in years) at the time of the desmopressin infusion will be compared to primary outcome measures from 2 to 9. This analysis will be performed at the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2. |
| Secondary | Influence of weight on the factor VIII pharmacokinetics after the desmopressin infusion | Through study completion, an average of 1 year | Weights (in kilograms) at the time of the desmopressin infusion will be compared to primary outcome measures from 2 to 9. This analysis will be performed at the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2. |
| Secondary | Influence of the desmopressin dose on the factor VIII pharmacokinetics after the desmopressin infusion | Through study completion, an average of 1 year | The dose of infused desmopressin (µg/Kg) will be compared to primary outcome measures from 2 to 9. This analysis will be performed at the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2. |
| Secondary | Influence of the blood group on the factor VIII pharmacokinetics after desmopressin infusion | Through study completion, an average of 1 year | Blood groups will be collected in the medical files and will be compared to primary outcome measures from 2 to 9. This analysis will be performed at the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2. |
| Other | Influence of polymorphism CLEC4 on the post-DDAVP half-life of FVIII | Through study completion, an average of 1 year | CLEC4 is a clearance receptor of factor VIII and von Willebrand factor. Its polymorphisms will be analyzed by sequencing with Sanger method. Results will be compared to the post-DDAVP FVIII half-life. This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available DNA of included patients. |
| Other | Influence of the DDAVP Cmax after its infusion on the post-DDAVP Cmax of FVIII | Through study completion, an average of 1 year | Measures of DDAVP level will be performed just before and after the DDAVP infusion from plasma samples systematically stocked following the standard care. The Cmax of DDAVP will be compared to the post-DDAVP FVIII peak (Cmax). This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available plasmas of included patients. |
| Other | Influence of polymorphism STAT-2 on the post-DDAVP half-life of FVIII | Through study completion, an average of 1 year | STAT-2 is a clearance receptor of factor VIII and von Willebrand factor. Its polymorphisms will be analyzed by sequencing with Sanger method. Results will be compared to the post-DDAVP FVIII half-life. This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available DNA of included patients. |
| Other | Influence of polymorphism LRP1 on the post-DDAVP half-life of FVIII | Through study completion, an average of 1 year | LRP1 is a clearance receptor of factor VIII and von Willebrand factor. Its polymorphisms will be analyzed by sequencing with Sanger method. Results will be compared to the post-DDAVP FVIII half-life. This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available DNA of included patients. |
| Other | Influence of polymorphism LDLR on the post-DDAVP half-life of FVIII | Through study completion, an average of 1 year | LDLR is a clearance receptor of factor VIII and von Willebrand factor. Its polymorphisms will be analyzed by sequencing with Sanger method. Results will be compared to the post-DDAVP FVIII half-life. This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available DNA of included patients. |
| Other | Influence of polymorphism STAB2 on the post-DDAVP half-life of FVIII | Through study completion, an average of 1 year | LDLR is a clearance receptor of factor VIII and von Willebrand factor. Its polymorphisms will be analyzed by sequencing with Sanger method. Results will be compared to the post-DDAVP FVIII half-life. This analysis will be performed after the total completion of the study with both cohorts GIDEMHA-1 and GIDEMHA-2, from the available DNA of included patients. |
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.
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