Trial · NCT06963216
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
NCT06963216, Phase 3, Withdrawn, Kedrion S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis. Trials, record NCT06963216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06963216
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
- NCT number
- NCT06963216
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Kedrion S.p.A.
- Conditions
- Acquired Factor X Deficiency
- Interventions
- Coagadex(R)
- First posted
- 2025-05-08
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the On-Demand Treatment Cohort | at 72 hours | Proportion of bleeding events with a 'positive' response. |
| Primary | Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the Surgery/Invasive Procedures Cohort | at 72 hours | Proportion of bleeding events with a 'fair, good, or excellent' response. |
| Secondary | Proportion of bleeding events responsive to Coagdex® therapy at Different Timepoints After 72 hours in the On- Demand Cohort | Day 4 to day 30 | Investigators will assess Coagadex® efficacy in the on-demand treatment cohort by looking at: -Percentage of responsive bleedings, -The ability to discontinue or reduce the dose and/or dosing frequency of Coagadex®. |
| Secondary | To assess the safety of Coagadex® by number and percentage of infusion related AEs, SAEs, coded by MedDRA | Day 0 through study completion, an average of up to 6 months. | To assess the safety of Coagadex® in the on-demand treatment of bleeding and management of peri-operative/peri-procedural hemostasis in infusion related AEs and SAEs. AEs and SAEs will be evaluated following the first Coagadex® administration: assessment of seriousness, causality assessment; and incidence, frequency, and severity of AEs and incidence and frequency of SAEs. |
| Secondary | Proportion of bleeding events responsive to Coagdex® therapy at Different Timepoints After 72 hours in Surgery/Invasive Procedures Cohort | Day 4 to Day 14 | Investigators will assess Coagadex® efficacy in the surgery/invasive procedures cohort by looking at: * The overall percentage of bleeding episodes successfully controlled, * The ability to discontinue or reduce the dose and/or dosing frequency of Coagadex®. |
| Secondary | Coagadex® exposure | Day 1 to Day 30 | Assess the number of study drug exposure days (overall and per participant) and the Coagadex® exposure per event. |
| Secondary | Assess Post-treatment FX Levels | Day 1 to Day 30 | Assess in the on-demand treatment cohort and surgery/invasive procedures cohort by FX:C IU/mL |
| Secondary | Assess bleeds at other sites. | Last Coagadex® until study completion, an average of up to 6 months. | Description: Assessed in the surgery/invasive procedures cohort by looking at: Number of sites per participant including severity, duration, location, and cause. |
| Secondary | Assess the pharmacokinetics(PK) of Coagadex® in peri-operative/peri-procedural hemostasis in Surgery/Invasive Procedures Cohort. | Day 0 pre-dose to Day 5 | To assess the pharmacokinetics(PK) of Coagadex® in peri-operative/peri-procedural hemostasis by PK parameter Maximum Plasma Concentration \[Cmax\] |
Source ClinicalTrials.gov
Outcomes0
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/NCT06963216
GET https://conductscience.org/api/trials/v1/NCT06963216/registered