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TAK-079 for Primary Immune Thrombocytopenia

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable
Diagnosis of ITP supported by a prior response to an ITP therapy (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥50,000/μL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 32
Awards & highlights

Study Summary

This trial is testing a drug called TAK-079 in people with primary immune thrombocytopenia (ITP), a rare disease that results in low levels of platelets. The goal is to see if the drug is safe and if it can increase the platelet count.

Who is the study for?
Adults with persistent or chronic primary immune thrombocytopenia (ITP) who have low platelet counts and have been on a stable ITP treatment for at least 4 weeks. They must not be taking certain medications like anticoagulants, antiplatelets, or recent monoclonal antibodies and should not have had a splenectomy within the last 3 months.Check my eligibility
What is being tested?
The trial is testing TAK-079's safety and effectiveness in increasing platelet counts compared to a placebo. Participants will receive weekly injections of either TAK-079 or placebo alongside their current ITP treatments for two months, followed by additional follow-up periods.See study design
What are the potential side effects?
Potential side effects of TAK-079 are not specified but may include reactions at the injection site, general discomfort, or other immune-related effects due to its nature as an immunomodulating agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ITP for 3 months or more.
Select...
I have ITP and responded to treatment before, reaching a platelet count of 50,000 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event (AE) Leading to TAK-079 Discontinuation
Secondary outcome measures
Percentage of Participants with Clinically Meaningful Platelet Response
Percentage of Participants with Complete Platelet Response
Percentage of Participants with Hemostatic Platelet Response
+1 more

Side effects data

From 2022 Phase 2 trial • 36 Patients • NCT04159805
17%
Pyrexia
8%
Depression
8%
Diplopia
8%
Atrioventricular block first degree
8%
Suicidal ideation
8%
Malaise
8%
Conjunctivitis allergic
8%
Dysarthria
8%
Dyspnoea exertional
8%
Fatigue
8%
Injection site pain
8%
Muscular weakness
8%
Paraesthesia
8%
Influenza like illness
8%
Lymphocyte count decreased
8%
Myasthenia gravis
8%
Parosmia
8%
Periorbital oedema
8%
Visual impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-079 Placebo-matching
TAK-079 300 mg
TAK-079 600 mg

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: OLE Phase, TAK-079 Dose 3Experimental Treatment1 Intervention
Participants who received placebo in double-blind Part B and opt to receive further treatment will receive TAK-079 Dose 3, SC injection QW for 8 weeks in OLE Phase of Part B.
Group II: Part B: Double Blind, TAK-079 Dose 3Experimental Treatment1 Intervention
TAK-079 Dose 3, SC injection QW for 8 weeks.
Group III: Part A: Open-label Extension (OLE) Phase, TAK-079 Dose 1Experimental Treatment1 Intervention
Participants who received placebo in double-blind Part A and opt to receive further treatment will be randomized to receive TAK-079 Dose 1, SC injection QW for 8 weeks in OLE Phase of Part A.
Group IV: Part A: OLE Phase, TAK-079 Dose 2Experimental Treatment1 Intervention
Participants who received placebo in double-blind Part A and opt to receive further treatment will be randomized to receive TAK-079 Dose 2, SC injection QW for 8 weeks in OLE Phase of Part A.
Group V: Part A: Double Blind, TAK-079 Dose 2Experimental Treatment1 Intervention
TAK-079 Dose 2, SC injection QW for 8 weeks.
Group VI: Part A: Double Blind, TAK-079 Dose 1Experimental Treatment1 Intervention
TAK-079 Dose 1, SC injection QW for 8 weeks.
Group VII: Part B: Double Blind, PlaceboPlacebo Group1 Intervention
TAK-079 placebo-matching injection SC, QW for 8 weeks.
Group VIII: Part A: Double Blind, PlaceboPlacebo Group1 Intervention
TAK-079 placebo-matching injection subcutaneously (SC) once weekly (QW) for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-079
2014
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,221 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,873 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.
197 Previous Clinical Trials
63,206 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04278924 — Phase 2
Thrombocytopenic Purpura Research Study Groups: Part A: Open-label Extension (OLE) Phase, TAK-079 Dose 1, Part B: Double Blind, Placebo, Part B: OLE Phase, TAK-079 Dose 3, Part A: Double Blind, Placebo, Part A: Double Blind, TAK-079 Dose 1, Part B: Double Blind, TAK-079 Dose 3, Part A: Double Blind, TAK-079 Dose 2, Part A: OLE Phase, TAK-079 Dose 2
Thrombocytopenic Purpura Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04278924 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278924 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any existing precedence for this research?

"The development of TAK-079 began in 2019, with the first clinical trial being funded by Takeda. After a successful Phase 1 study involving 50 patients, additional trials have been conducted across 58 cities and 18 countries today."

Answered by AI

What is the projected result of this clinical experiment?

"According to the sponsors of this trial, Millennium Pharmaceuticals Inc., the main objective will be gauged over a 16 week period. This examination is focused on establishing the percentage of participants that experience at least one Grade 3 or higher treatment related adverse event (TEAE), serious adverse event (SAE) and/or an AE causing discontinuation of TAK-079. Additionally, secondary outcomes such as complete platelet response rate, clinically meaningful platelet response rate and hemostatic platelet response rate are also being evaluated."

Answered by AI

Has TAK-079 been field tested in any other medical experiments?

"Presently, there are 4 trials studying the effects of TAK-079 with none in Phase 3. Numerous trial sites exist across 92 different locations; most notably Taipei and Aiti."

Answered by AI

In what locales is this research experiment taking place?

"At the moment, seven medical centres are enrolling patients in this trial. These locales include Greenville, Gainesville and Tucson as well as other nearby cities. To reduce travel requirements for participants who do join the study, it is preferable to choose a site close to home."

Answered by AI

What is the upper limit of participants involved in this clinical trial?

"This trial necessitates 54 individuals who meet the eligibility requirements to participate. Patients can access this medication in two places, including Leo W. Jenkins Cancer Center located in Greenville (North carolina), and University of Florida at Gainesville (Florida)."

Answered by AI

Is this trial currently open to participants?

"Affirmative. The clinicaltrials.gov database indicates that this research project, which was first published on November 9th 2020, is currently looking for participants. 54 volunteers are sought from 7 distinct healthcare settings."

Answered by AI

Has the FDA sanctioned the use of TAK-079?

"Our team at Power has evaluated the safety of TAK-079 to be a 2 due to limited evidence that suggests its efficacy but some data supporting safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
2020. "A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278924.
All > Thrombocytopenia
~3 spots leftby Aug 2024
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