RECRUITING

A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response in Part 1 or platelet response in Part 2. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

Official Title

A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in the Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Quick Facts

Study Start:2023-03-21
Study Completion:2026-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05714969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

University of Florida - Shands
Gainesville, Florida, 32610
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Minnesota Clinical Research Unit
Minneapolis, Minnesota, 55455
United States
Rutgers University
New Brunswick, New Jersey, 08901
United States
Weill Cornell
New York, New York, 10021
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, 27858
United States
Ohio State University
Columbus, Ohio, 43210
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
United States
Versiti Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-21
Study Completion Date2026-06-11

Study Record Updates

Study Start Date2023-03-21
Study Completion Date2026-06-11

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy
  • Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Additional Relevant MeSH Terms

  • Thrombotic Thrombocytopenic Purpura (TTP)