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New treatment option for Immune-mediated Thrombotic Thrombocytopenic Purpura
Official title A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
ClinicalTrials.gov ID: NCT06831058
What this study is testing
What is efgartigimod?
efgartigimod is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for immune-mediated thrombotic thrombocytopenic purpura.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Immune-mediated Thrombotic thrombocytopenic purpura (iTTP) is a rare, autoimmune disorder characterized by life-threatening episodes of thrombocytopenia, microangiopathic hemolytic anemia and organ damage. Patients have an unpredictable course punctuated by relapses associated with autoantibody-mediated (primarily IgG) depletion of ADAMTS13, a key regulator of coagulation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must provide a signed informed consent form
- Subject is 18 years or older at the time of screening
- Subject has a prior history of iTTP as defined by the presence of ADAMTS13 activity \< 10% with ADAMTS13 antibodies or inhibitor, thrombocytopenia...
- Subject is in clinical remission from iTTP (normal platelet count) for at least 90 days
- Subject has ADAMTS13 activity \ 30% on 2 separate occasions separate by at least 7 days
You likely can't join if
- Subject has been diagnosed with cTTP
- Subject has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical...
- Subject is unable to understand the nature, scope, and possible consequences of the study.
- Subject is pregnant or lactating
- Subject has a known life-threatening hypersensitivity reaction to efgartigimod
See the full eligibility criteria
- Subject must provide a signed informed consent form
- Subject is 18 years or older at the time of screening
- Subject has a prior history of iTTP as defined by the presence of ADAMTS13 activity \< 10% with ADAMTS13 antibodies or inhibitor, thrombocytopenia (platelet count \< 100) and microangiopathic hemolytic anemia (defined...
- Subject is in clinical remission from iTTP (normal platelet count) for at least 90 days
- Subject has ADAMTS13 activity \ 30% on 2 separate occasions separate by at least 7 days
- Subject is at least 6 months from last dose of rituximab or other intravenous immunosuppression
- If taking other oral immunosuppressants, no change in dose for at least 60 days
- Female people of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study. Sexually active male people must agree to use an...
- Subject has been diagnosed with cTTP
- Subject has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during...
- Subject is unable to understand the nature, scope, and possible consequences of the study.
- Subject is pregnant or lactating
- Subject has a known life-threatening hypersensitivity reaction to efgartigimod
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.