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

1Hemophilia
Amy Shapiro, MD has run 5 trials for Hemophilia. Some of their research focus areas include:
pdFVIII
rFVIII
FFP
2Hemophilia 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 American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate 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.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, 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. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. 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.(7)
Recruiting1 award N/A1 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.
Recruiting4 awards Phase 4

More about Amy Shapiro, MD

Clinical Trial Related5 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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