Dr. Amy D. Shapiro, MD | Indianapolis ...

Dr. Amy Shapiro, MD

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Indiana Hemophila @Thrombosis Center

Studies Hemophilia
Studies Hemophilia A
9 reported clinical trials
11 drugs studied

Area of expertise

1

Hemophilia

Amy Shapiro, MD has run 5 trials for Hemophilia. Some of their research focus areas include:

pdFVIII
rFVIII
FFP
2

Hemophilia A

Amy Shapiro, MD has run 4 trials for Hemophilia A. Some of their research focus areas include:

pdFVIII
rFVIII
FFP

Affiliated Hospitals

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Indiana Hemophila @Thrombosis Center

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Indiana Hemophilia And Thrombosis Center (IHTC)

Clinical Trials Amy Shapiro, MD is currently running

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Natural History Study

for Blood Disorders

In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.2,3,4,5 In 2019 alone, the FDA has issued approvals for 24 new therapies for congenital and acquired hematologic conditions.6 In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.7 With this increase in potential new therapies possible, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.8

Recruiting

1 award

N/A

1 criteria

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Hemlibra

for Mild Hemophilia A

This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVIII activity of \>5% to 30%). The safety and hemostatic efficacy of Hemlibra (emicizumab) in this patient population will be investigated. Secondary outcomes will assess changes in joint health and quality of life in treated patients.

Recruiting

4 awards

Phase 4

More about Amy Shapiro, MD

Clinical Trial Related

5 years of experience running clinical trials · Led 9 trials as a Principal Investigator · 3 Active Clinical Trials

Treatments Amy Shapiro, MD has experience with

  • Emicizumab
  • Liver Transplantation
  • Clotting Factor Replacement Product
  • Various VWF Regimens
  • RFVIII
  • RVWF

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