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Clotting Factor

prophylaxis for Acquired Hemophilia (ENJOIH Trial)

Phase 2
Waitlist Available
Led By Elena Santagostino, MD, PhD
Research Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop high-titer inhibitors.

Eligible Conditions
  • Acquired Hemophilia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 2 trial • 92 Patients • NCT00810888
60%
Constipation
50%
Urinary tract infection
50%
Headache
50%
Hypertension
30%
Hypokalemia
30%
Depression
30%
Urinary retension
30%
Nausea
30%
Fever
20%
Hyponatremia
20%
Bradycardia
20%
Fall from bed
20%
Respiratory distress
20%
Dysphagia
20%
Leukocytosis
20%
Back pain
10%
Hypocalcemia
10%
Bruising on forearms
10%
Leg pain
10%
Somulence
10%
Anxiety
10%
Aneurysm
10%
Malignant hypertension
10%
Tachycardia
10%
Hyperglycemia
10%
Generalized pain
10%
Pain with catherization
10%
Cerebral Edema
10%
Elevated Troponin
10%
Seizure
10%
Tracheitis
10%
ELEVATED ERYTHROCYTE SEDIMENTATION RATE
10%
Prolonged prothrombin time
10%
Right shoulder rotator cuff tear
10%
Confusion
10%
Hematuria
10%
Pleural effusion
10%
Hypotension
10%
Increasing mass effect
10%
POSSIBLE MCA VESSEL THROMBOSIS WITHOUT ISCHEMIC STROKE
10%
Significant expansion of ICH
10%
Acute exacerbation of renal failure
10%
Pulmonary embolism
10%
Distended abdomen
10%
Rectal pain
10%
Elevated troponin
10%
Gram negative bacteremia
10%
Deep vein thrombosis (DVT)
10%
Hemorrhage expansion
10%
Leukopenia
10%
Diarrhea
10%
Candidiasis
10%
Chest pain
10%
Cough
10%
Nasal congestion
10%
Renal failure
10%
O2 desats on ventilator
10%
RESPIRATORY DISTRESS SECONDARY TO TRACH OBSTRUCTION
10%
Congestive heart failure
10%
Right hand PIV infultration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 - Randomized to Study Drug
Group 2 - Randomized to Placebo
Group 3 - Observation Only Arm

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: prophylaxisExperimental Treatment1 Intervention
prophylaxis with recombinant activated FVII 90 µg/kg/day i.v.
Group II: on demand treatmentActive Control1 Intervention
treatment of bleeding episodes with 270 µg/kg (first/single dose) or 90 µg/kg i.v. every 2-3 hours until bleeding resolution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coagulation factor VII human
FDA approved

Find a Location

Who is running the clinical trial?

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoLead Sponsor
240 Previous Clinical Trials
471,082 Total Patients Enrolled
Elena Santagostino, MD, PhDPrincipal InvestigatorFondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano
2 Previous Clinical Trials
205 Total Patients Enrolled
~3 spots leftby Nov 2025
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