Trial · NCT05628558
Genetic Influence of Genetic Factors Influencing the Desmopressin's Efficacy in Mild/Moderate Hemophilia A
NCT05628558, Unknown, Groupe Maladies hémorragiques de Bretagne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genetic Influence of Genetic Factors Influencing the Desmopressin's Efficacy in Mild/Moderate Hemophilia A. Trials, record NCT05628558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05628558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genetic Influence of Genetic Factors Influencing the Desmopressin's Efficacy in Mild/Moderate Hemophilia A
- NCT number
- NCT05628558
- Status
- Unknown
- Enrollment
- 800 participants, estimated
- Lead sponsor
- Groupe Maladies hémorragiques de Bretagne
- Conditions
- Hemophilia A, Mild, Desmopressin, Factor VIII
- Interventions
- Desmopressin
- First posted
- 2022-11-28
- Last updated
- 2022-11-28
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 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/NCT05628558
GET https://conductscience.org/api/trials/v1/NCT05628558/registered?page=2