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Virus Therapy
TAK-755 for Thrombotic Thrombocytopenic Purpura
Phase 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has been diagnosed with de novo or relapsed iTTP.
Participant is 18 years or older at time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 12 weeks
Awards & highlights
Study Summary
This trial determines the effectiveness of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). Participants take TAK-755 & immunosuppressive therapy for 3 months.
Who is the study for?
Adults diagnosed with iTTP who haven't had more than two plasma exchanges before the study can join. They must be willing to use effective birth control, follow study rules, and give consent. Those with severe allergies to TAK-755 components, recent other investigational treatments, or certain health conditions like unstable HIV cannot participate.Check my eligibility
What is being tested?
The trial tests TAK-755 in adults with iTTP to see if they can respond clinically without needing plasma exchange. Participants will receive TAK-755 along with immunosuppressive therapy during an acute attack and for up to six weeks after, totaling about three months of study involvement.See study design
What are the potential side effects?
Potential side effects of TAK-755 may include allergic reactions such as anaphylaxis due to its ingredients or related proteins from Chinese hamster ovary cells used in its production.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with iTTP for the first time or it has come back.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP)
Secondary outcome measures
A Disintegrin and Metalloproteinase With Thrombospondin Motifs 13 (ADAMTS13) Antigen Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
ADAMTS13 Activity Level Resulting From TAK-755 Administration in Acute and Post-Acute Phases
Achievement of Clinical Remission
+17 moreSide effects data
From 2022 Phase 1 trial • 19 Patients • NCT0399776025%
Sickle cell anaemia with crisis
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
Blood lactate dehydrogenase increased
25%
Dizziness
25%
Foot fracture
25%
Hypokalaemia
25%
Nasal congestion
25%
Nausea
25%
Pain
25%
Pyrexia
25%
Vomiting
25%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
TAK-755: 40 IU/kg
TAK-755: 80 IU/kg
TAK-755: 160 IU/kg
Trial Design
2Treatment groups
Experimental Treatment
Group I: TAK-755 Dose 2 in Both Acute and Post-Acute PhaseExperimental Treatment1 Intervention
TAK-755 Dose 2, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
Group II: TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute PhaseExperimental Treatment1 Intervention
TAK-755 Dose 1, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-755
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,994 Total Patients Enrolled
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,985 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,313 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a life-threatening illness with a life expectancy of less than 3 months.I am currently suffering from a severe infection.I have been diagnosed with a condition that causes blood clots in small vessels.I cannot take methylprednisolone or similar steroids due to a health condition.I have had more than 2 plasma exchange treatments before joining the study.I had an iTTP event in the last 30 days.You have HIV with an unstable condition or a CD4+ count of less than 200 cells/mm^3 within the last 3 months.I have taken caplacizumab within the last 30 days.I have not been part of another drug study in the last 30 days and won't join another during this study.You had a severe allergic reaction to certain ingredients in the study drug before.I have been diagnosed with iTTP for the first time or it has come back.I am using or agree to use effective birth control during the study.I am 18 years old or older.I have a severe immune system deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: TAK-755 Dose 2 in Both Acute and Post-Acute Phase
- Group 2: TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently being recruited to the clinical trial?
"The study necessitates 40 individuals who meet the necessary criteria to participate. These participants can be found in Weill Cornell Medical College New york Presbyterian Hospital, located in New York City or Duke University Medical Center situated in Durham, North carolina."
Answered by AI
How many medical establishments are administering this investigation?
"For this clinical trial, Weill Cornell Medical College New york Presbyterian Hospital in New York City, Duke University Medical Centre situated in Durham, North carolina and Leo Jenkins Cancer Center/ECU School of Medicine located in Greenville, Ohio are some of the participating sites. An additional 27 medical facilities have also been recruited to participate."
Answered by AI
Are there any unfilled spots in the experiment for eligible candidates?
"Indeed, clinicaltrials.gov reveals that the search for participants is ongoing. This research project was initially made public on March 21st 2023 and amended most recently on March 24th 2023. Forty individuals will be admitted to 27 sites across the country."
Answered by AI
Could you explain the safety profile of TAK-755 Dose 2 during both acute and post-acute phases?
"Our team has assigned TAK-755 Dose 2 a rating of 2 for safety, as there is limited proof of its efficacy but existing evidence suggests it does not pose major risk."
Answered by AI
Who else is applying?
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
The Purpura looks gross on my body.
PatientReceived no prior treatments
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