A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis

Conditions

• Acquired Factor X Deficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Coagadex(R) — BIOLOGICAL
  Coagulation Factor X (Human)

Study Details

The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.

Key Dates

Start date

Jun 30, 2026

Status verified

Feb 2026

Primary completion

Jun 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: On-Demand Treatment Cohort
  Participants without an active bleeding event will enter the Run-In Period, which lasts up to 180 days. Upon a bleeding event participants will receive a first dose of 40 IU/kg of Coagadex®. Additional dose(s) will be based on the incremental recovery (IR). (If an allowed Emergent Surgery becomes necessary in the Run-In Period, the participant will cross over into the Surgery/Invasive Procedures Cohort.)
• Experimental: Surgery/Invasive Procedures Cohort
  Participants enrolled at least 3 weeks prior to a scheduled surgical intervention will undergo pharmacokinetic sampling. The dose of Coagadex® will be determined based on the patient's PK profile. (During this 3-week period, if the participant develops an acute bleed, they will cross over into the On-Demand Treatment Cohort for treatment.)

Primary Outcome Measure

Proportion of bleeding events responsive to Coagdex® therapy at 72 hours after initiation of treatment in the On-Demand Treatment Cohort [ Time Frame: at 72 hours ]

Central Contacts

• Nicola Rovai
  +39 335 6524750
  [email protected]

Locations (2)

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