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BAX 930 for TTP
Study Summary
This trial is testing a new treatment, BAX 930, for people with thrombotic thrombocytopenic purpura (TTP), a condition where blood clots form in small blood vessels throughout the body. The study will compare the number of TTP events in people treated with BAX 930 versus those treated with the standard treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My doctor expects I have less than 3 months to live due to my illness.I have been diagnosed with a condition similar to TTP, including acquired TTP.I am currently sick with a condition like the flu or asthma.You have had problems with drugs or alcohol in the past two years.I had a recent TTP episode less than 30 days ago.I have a weak immune system that could affect vaccine testing, including HIV with low CD4 counts or I'm on long-term immune-weakening medication.I have liver problems, shown by high ALT levels, very low albumin, or signs of portal vein hypertension.You are allergic to proteins from hamsters.My doctor thinks I have another serious health condition that could increase my risk in this trial.I have taken immune system affecting drugs, not including skin creams or nasal sprays, in the last 30 days.I have a severe hereditary ADAMTS13 deficiency confirmed by genetic testing.I am between 0 and 70 years old.I don't have severe blood clotting issues or very low platelets.I cannot take standard medications due to health reasons.I, or my legal guardian, have signed the consent form and I am 18 years or older.I am on, or can tolerate, standard preventive treatment for blood clots.I am not pregnant or breastfeeding.I have been diagnosed with severe heart disease.You have a medical history or currently have a substance in your body that affects a specific enzyme called ADAMTS13.I am not pregnant, can take a pregnancy test, and will use birth control during the study.I either don't have hepatitis C, or if I do, it's stable and chronic.I am over 16 and can care for myself, or if under 16, I can do most activities.I am on chronic dialysis for end-stage kidney disease.I am using effective birth control and will continue for at least 16 days after my last treatment.I understand the study and am willing to cooperate.
- Group 1: Prophylaxis Cohort II
- Group 2: On Demand Cohort II
- Group 3: On Demand Cohort I
- Group 4: Prophylaxis Cohort I
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are we still looking for patients who want to participate in this experiment?
"This clinical trial, which was first posted on October 13, 2017 and last updated on May 4, 2022, is currently searching for participants."
Might I be eligible for this experiment?
"This trial is looking for 57 people with thrombotic thrombocytopenic purpura (ttp) between the ages of 0 and 70. Most notable, candidates should meet the following criteria: Participant is currently on a prophylactic dosing regimen or has a documented history of at least 1 TTP event and an ability to tolerate SoC prophylactic dosing (prophylactic cohort only)., If female of childbearing potential, participant presents with a negative blood or urine pregnancy test, confirmed no more than 7 days before the first administration, and agrees to employ adequate birth control measures for the duration"
Are there different versions of this study taking place in different states?
"This trial is recruiting at various locations including Durham's Duke University Medical Center, Oklahoma City's University of Oklahoma, and Atlanta's Winship Cancer Institute. There are a total of 6 recruiting sites."
Are geriatric patients within the scope of this research?
"This clinical trial is recruiting people who are between 0 and 70 years old."
Could you please give some clarity on the potential risks of BAX930?
"BAX930's safety is based on data from previous Phase 3 trials, and it was given a score of 3."
Are there any other similar studies ongoing at this time?
"BAX930 has a long clinical history, with the first study taking place in 2017. The trial was sponsored by Takeda Development Center Americas, Inc.. After this initial Phase 1 study involving 57 people, BAX930 received approval for Phase 3 trials. Now, there are 2 active studies being conducted in 20 cities and 10 countries around the world."
How many patients have been recruited for this clinical trial?
"In order to move forward, this trial requires 57 individuals that match the pre-determined inclusion criteria. These participants can come from different hospitals, such as Duke University Medical Center or University of Oklahoma."
Could you please elaborate on other research that has included BAX930?
"BAX930 is being trialled in 2 Phase 3 studies currently underway. 51 different research sites are conducting investigations into BAX930, with many of them located in Fukuoka-shi, Fukuoka-Ken."
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