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Last Updated: April 16, 2021

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CLINICAL TRIALS PROFILE FOR ADYNOVATE

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All Clinical Trials for ADYNOVATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04690322 POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies Not yet recruiting Jessica Garcia Phase 4 2021-01-01 This is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor VIII based replacement therapy or non-FVIII based replacement therapy, which are both standard of care treatment for persons with Hemophilia A.
NCT04784988 Intensive Replacement Treatment in Haemophilia Patients With Synovitis Not yet recruiting Federico II University Phase 4 2021-03-01 Background: Joint haemorrhage represents the most common type of bleeding episode in persons with hemophilia (PwH). In the absence of an adequate prophylaxis with Factor VIII (for hemophilia A) or FIX (for hemophilia B) concentrates up to 85% of patients with severe hemophilia develop a clinically overt joint disease. Screening of early signs of arthropathy is needed. Synovitis is widely considered as one of the parameters to be taken into account for the diagnosis and the surveillance of joint impairment in PwH. Aim: To assess if an intensive factor VIII replacement treatment is able at reverting synovitis in PwH. Methods: The present study is a randomized, open-label, cross-over study. Among patients referred to enrolling Haemophilia Centres, consecutive patients with severe (FVIII < 1%) or severe-moderate (FVIII < 2%) haemophilia A without inhibitors will be enrolled. The present study will be organized in 2 phases. - Phase 1 (US screening): All patients will undergo an ultrasound examination of elbows, ankles and knees to define joint status and to identify presence/absence of synovitis according to the HEAD-US system. - Phase 2 (Intervention): Patients with US evidence of synovitis will be randomly assigned at undergoing a PK assessment with my-PK-fit to start a prophylaxis with Adynovi® targeting a 12% FVIII through level (PROPEL-like arm) or to continue ongoing standard treatment (control arm). US examination of the six joints will be repeated monthly for six months and in case of onset of symptoms that might suggest an acute bleeding episode. After six months the two treatment arm will be switched in the frame of a cross-over approach and all PwH will be followed for other 6 months The primary outcome will be represented by changes in synovial status during the intensive factor VIII replacement treatment vs standard treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ADYNOVATE

Condition Name

Condition Name for ADYNOVATE
Intervention Trials
Hemophilia A 2
Factor VIII 1
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Condition MeSH

Condition MeSH for ADYNOVATE
Intervention Trials
Hemophilia A 2
Synovitis 1
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Clinical Trial Locations for ADYNOVATE

Trials by Country

Trials by Country for ADYNOVATE
Location Trials
United States 1
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Trials by US State

Trials by US State for ADYNOVATE
Location Trials
Texas 1
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Clinical Trial Progress for ADYNOVATE

Clinical Trial Phase

Clinical Trial Phase for ADYNOVATE
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for ADYNOVATE
Clinical Trial Phase Trials
Not yet recruiting 2
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Clinical Trial Sponsors for ADYNOVATE

Sponsor Name

Sponsor Name for ADYNOVATE
Sponsor Trials
Federico II University 1
Jessica Garcia 1
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Sponsor Type

Sponsor Type for ADYNOVATE
Sponsor Trials
Other 2
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