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Iptacopan for Blood Diseases
Study Summary
This trialis testing a new drug to treat blood disorders like low platelet count or cold agglutinin disease.
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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- I am using birth control if I can get pregnant and will continue for 1 week after my last dose.I am not on any treatments specifically for coronary artery disease.I have cold agglutinin syndrome not caused by a low-grade blood cancer.I have been diagnosed with long-term primary ITP.I have not had any infections in the last 14 days.Your blood clotting tests show abnormal results.I have long-term low red blood cell counts.I have had a bone marrow, stem cell, or organ transplant.I have been diagnosed with coronary artery disease.I have liver disease or injury shown by liver tests.I am only on stable low-dose steroids or thrombopoietin receptor agonists for my ITP.You have a long-lasting low platelet count.I weigh at least 35 kg.There is ongoing evidence of red blood cell breakdown in your blood tests.My low platelet count is due to another health condition.I have been treated for ITP with at least one type of therapy.I have had at least one treatment for coronary artery disease.I am vaccinated against meningitis and pneumonia, and it's recommended I get the flu shot before treatment.I am vaccinated against meningitis and pneumonia, and it's recommended I get the flu shot before treatment starts.I have CAD, received at least one treatment for it, and I have ongoing hemolysis and anemia.I weigh at least 35 kg.I have severe bleeding or a history of bleeding in the brain.I am not taking any medications that the study does not allow.I have chronic ITP and have tried at least one treatment for it.I haven't had cancer in the last 5 years, except for certain skin, cervical cancers, or low-grade blood disorders.I have a known or suspected genetic or acquired issue with my immune system.You have a history of immune system problems, including testing positive for HIV.I have a long-term hepatitis B or C infection.I have had repeated serious infections caused by certain bacteria.
- Group 1: Iptacopan 200 mg BID
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the FDA granted authorization for Iptacopan 200 mg BID?
"The safety of Iptacopan 200 mg BID is estimated to be a 2 as this Phase 2 trial has yielded evidence regarding its security, yet no data that can attest to its effectiveness."
How many subjects are receiving the experimental treatment in this clinical experiment?
"Affirmative, the clinicaltrials.gov page indicates that this research is actively enrolling participants. It was posted on December 21st 2021 and recently revised November 30th 2022. Thirty individuals are required for the single site trial."
Does this clinical trial represent a pioneering effort?
"Since 2019, Novartis Pharmaceuticals has been researching the effects of Iptacopan 200 mg BID. After its initial trial in which 95 participants were enrolled, this medication received Phase 2 drug approvals and is currently being studied by 10 active teams present in 169 cities and 39 nations."
Are there any opportunities for volunteers to participate in this research project?
"Based on the information available through clinicaltrials.gov, this research study is still accepting participants. The trial was initially posted in December of 2021 and most recently amended on November 30th 2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Most responsive sites:
- Massachusetts General Hospital: < 24 hours
Average response time
- < 1 Day
Typically responds via
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