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Efgartigimod PH20 SC for Thrombocytopenic Purpura (ADVANCE SC Trial)
ADVANCE SC Trial Summary
This trial is testing a new drug to see if it's effective, safe, and improves quality of life for people with primary ITP.
- Idiopathic Thrombocytopenic Purpura (ITP)
ADVANCE SC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ADVANCE SC Trial Design
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- You have received immunoglobulin (IV, SC, or intramuscular) or plasmapheresis treatment within the past 4 weeks before the study.You have low platelet count due to another medical condition, such as lymphoma, leukemia, viral infection, hepatitis, or a bone marrow transplant.You have had a bad allergic reaction to efgartigimod, rHuPH20, or any of the other ingredients in the medication.You have had issues with alcohol, drugs, or misusing medications within the past year.You have received a blood transfusion within the past 4 weeks before the study.Your blood pressure is not well controlled even with medication, and it consistently shows high readings above 160/100 mmHg.You have had a serious blood clot or blockage, like a heart attack or stroke, within the past 5 years.You are male or female, aged ≥18 years at the time the informed consent form (ICF) is signed.You have taken blood-thinning medications like warfarin or direct oral anticoagulants within the past 4 weeks.You have been diagnosed with a condition called ITP and have responded positively to a previous treatment, as determined by your doctor.You have other serious health conditions that are not well-controlled, such as heart, lung, blood, stomach, hormone, liver, kidney, brain, or cancer diseases.You have a history of blood clotting or low platelet count, or someone in your family has had these conditions.You have a high chance of experiencing severe bleeding in an organ or internal tissue that would require immediate treatment or medical procedures, as determined by the doctor.You have another autoimmune disease that could make it difficult to accurately assess your symptoms of ITP or could increase your risk of harm.
- Group 1: Efgartigimod PH20 SC
- Group 2: Placebo PH20 SC
- 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
Does this trial represent a new development in medical research?
"There are 4 ongoing clinical trials for Efgartigimod PH20 SC in 32 cities and 39 countries. The first study was completed in 2020 by argenx, which sponsored the 101 person trial that reached Phase 3 approval. In the 2 years since then, 10 more studies have concluded."
Is there a risk of long-term side effects with Efgartigimod PH20 SC?
"Efgartigimod PH20 SC is in Phase 3 clinical trials, meaning that there is evidence of efficacy and multiple rounds of data supporting safety. Consequently, our team has rated its safety as a 3."
Are patients currently being accepted for this trial?
"Yes, this is an ongoing clinical trial that was initially posted on December 11th 2020. The most recent update to the study occurred on October 12th 2022."
How many people can join this trial at most?
"A total of 219 individuals are required for this study. These participants must meet the specific inclusion criteria and can enroll at one of the many participating sites, such as Investigator Site 0010045 in Washington, D.C., or Investigator Site 0010062 in Fort Wayne, Indiana."
Are there any Efgartigimod PH20 SC research papers that have been published?
"Currently, there are 4 different clinical trials studying the effects of Efgartigimod PH20 SC. 3 of those studies are in Phase 3. Although most locations for these trials are based in Le Kremlin-Bicêtre or Florida, 406 research sites across the world are participating in this experiment."
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