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Monoclonal Antibodies

Emicizumab for Haemophilic Pseudotumour

Phase 4
Waitlist Available
Led By Amy D Shapiro, MD
Research Sponsored by Indiana Hemophilia &Thrombosis Center, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 months, for the 2 years and 10 months of the patient's study participation duration.
Awards & highlights

Study Summary

This study is evaluating whether a drug may help individuals with hemophilia A.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 months, for the 2 years and 10 months of the patient's study participation duration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 months, for the 2 years and 10 months of the patient's study participation duration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Hemoglobin
Hemostatic Efficacy of Prophylactic Weekly Injections of Hemlibra (Emicizumab) Based on Participants' Need for Blood Transfusions or Lack of
Secondary outcome measures
ADA and Activated Partial Thromboplastin Time (APTT)
ADA and Factor VIII (FVIII)
Adverse Events
+10 more

Side effects data

From 2022 Phase 3 trial • 48 Patients • NCT03020160
57%
ARTHRALGIA
57%
HEADACHE
43%
OSTEOARTHRITIS
43%
SYNOVITIS
29%
BACK PAIN
29%
PHARYNGITIS
29%
ODYNOPHAGIA
29%
CONTUSION
29%
EAR INFECTION
29%
UPPER RESPIRATORY TRACT INFECTION
29%
URINARY TRACT INFECTION
29%
HYPERTENSION
29%
Arthralgia
29%
Osteoarthritis
29%
Headache
29%
Upper respiratory tract infection
29%
Back pain
29%
ABDOMINAL PAIN
14%
CHOLELITHIASIS OBSTRUCTIVE
14%
CHEST PAIN
14%
FALL
14%
TOOTHACHE
14%
COVID-19
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
MYALGIA
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
MUSCULOSKELETAL CHEST PAIN
14%
EXOSTOSIS
14%
JOINT CONTRACTURE
14%
SUBCUTANEOUS ABSCESS
14%
HEAD INJURY
14%
DEVICE BREAKAGE
14%
JOINT LOCK
14%
TONGUE INJURY
14%
ARTHRITIS
14%
TINEA CAPITIS
14%
GINGIVAL INJURY
14%
PARAESTHESIA
14%
Injection site reaction
14%
MEDICAL DEVICE DISCOMFORT
14%
POST PROCEDURAL INFLAMMATION
14%
ANXIETY
14%
RASH
14%
Temporomandibular joint syndrome
14%
Post procedural inflammation
14%
INFLAMMATION
14%
INJECTION SITE REACTION
14%
Dyspepsia
14%
Device related infection
14%
Contusion
14%
Synovitis
14%
Tendon disorder
14%
Joint lock
14%
Cholelithiasis
14%
Myalgia
14%
HYPERCHOLESTEROLAEMIA
14%
VITAMIN D DEFICIENCY
14%
Abdominal pain
14%
Tongue injury
14%
Eczema eyelids
14%
Ear infection
14%
Osteitis
14%
Pharyngitis
14%
Hypertension
14%
Musculoskeletal chest pain
14%
IRON DEFICIENCY ANAEMIA
14%
ECZEMA EYELIDS
14%
DIARRHOEA
14%
DYSPEPSIA
14%
PYREXIA
14%
SEASONAL ALLERGY
14%
DEVICE RELATED INFECTION
14%
SPINAL OSTEOARTHRITIS
14%
TEMPOROMANDIBULAR JOINT SYNDROME
14%
TENDON DISORDER
14%
MOTOR DYSFUNCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Emicizumab: PK Run-In Cohort
Emicizumab: Expansion Cohort

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Patients with hemophilic pseudotumor will be treated with prophylactic emicizumab and assessed for improvement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emicizumab
FDA approved

Find a Location

Who is running the clinical trial?

Indiana Hemophilia &Thrombosis Center, Inc.Lead Sponsor
5 Previous Clinical Trials
685 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,898 Total Patients Enrolled
Amy D Shapiro, MDPrincipal Investigator - Indiana Hemophilia &Thrombosis Center, Inc.
Indiana Hemophilia &Thrombosis Center, Inc.
4 Previous Clinical Trials
685 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
HaemophiliaJournal
Health-related Quality of Life in Patients with Haemophilia and Inhibitors on Prophylaxis with Anti-inhibitor Complex Concentrate: Results from the Pro-feiba Study
Gringeri, A., C. Leissinger, P. A. Cortesi, H. Jo, F. Fusco, S. Riva, B. Antmen, et al.. 2013. “Health-related Quality of Life in Patients with Haemophilia and Inhibitors on Prophylaxis with Anti-inhibitor Complex Concentrate: Results from the Pro-feiba Study”. Haemophilia. Wiley. doi:10.1111/hae.12178.
Blood ReviewsJournal
Hemophilia A in the Third Millennium
Franchini, Massimo, and Pier Mannuccio Mannucci. 2013. “Hemophilia A in the Third Millennium”. Blood Reviews. Elsevier BV. doi:10.1016/j.blre.2013.06.002.
Journal of Thrombosis and HaemostasisJournal
Definitions in Hemophilia: Communication from the SSC of the ISTH
Blanchette, V. S., N. S. Key, L. R. Ljung, M. J. Manco-Johnson, H. M. van den Berg, A. Srivastava, and the Subcommittee on Factor VIII, Factor IX and Rare Coagulation Disorders. 2014. “Definitions in Hemophilia: Communication from the SSC of the ISTH”. Journal of Thrombosis and Haemostasis. Wiley. doi:10.1111/jth.12672.
clinicaltrials.govStudy
HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor
Amy D Shapiro, MD 2019. "HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03921294.
~0 spots leftby Apr 2025
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