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Sapablursen for Polycythemia Vera
Study Summary
This trial is testing whether a new drug can reduce the amount of blood taken from people with polycythemia vera and improve their quality of life.
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 have been diagnosed with PPV-MF according to IWG-MRT standards.I was diagnosed with polycythemia vera according to WHO 2016 criteria.I haven't had any serious bleeding or blood clotting issues in the last month.I haven't had cancer in the last 5 years, except for certain skin cancers, cervical carcinoma in situ, or treated non-metastatic prostate cancer.I haven't had or don't currently need treatment to reduce my blood cell counts. If I was treated, it ended 3 months ago.I do not have an active infection needing drugs or an ongoing COVID-19 infection.I have not had surgery under general anesthesia in the last month.I stopped my cytoreductive therapy 3 months ago or have been on a stable dose for the same duration.I do not have an active infection with HIV, hepatitis C, or hepatitis B.I experience moderate to severe pain in my spleen area.I have a diagnosed immune system disorder.
- 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.
- Group 1: Sapablursen Dose Level 1
- Group 2: Sapablursen Dose Level 2
Frequently Asked Questions
How many centers are actively managing this clinical trial?
"This clinical trial is presently accepting patients from 12 distinct sites. These locations include, but are not limited to Houston, San Antonio and Los Angeles; thus participants should consider enrolling in the nearest centre for minimal travel requirements."
Who is able to meet the criteria for participating in this research trial?
"To qualify for this trial, candidates must have polycythemia and range between 18 and 80 years of age. A total of 40 people are necessary to complete the research requirements."
Is the demographic of this research limited to individuals below forty years old?
"This clinical trial is open to people aged 18 to 80. Additionally, there are 2 studies available for minors and 53 trials designated specifically toward seniors over 65 years old."
Has the IONIS-TMPRSS6-LRx gained sanction from the Food and Drug Administration?
"Although there is no evidence yet to support its efficacy, the safety of IONIS-TMPRSS6-LRx was rated a 2 due to some data suggesting it has been well tolerated in Phase 2 trials."
What is the current enrollment for this clinical research?
"The sponsor, Ionis Pharmaceuticals, Inc., is looking to enroll 40 eligible participants in this trial from multiple sites such as Norris Comprehensive Cancer Center and University of Texas MD Anderson Cancer Center. These locations include Houston, Texas and San Antonio, New york respectively."
Are enrollments still open for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical investigation is still looking for participants - having been initially uploaded on December 30th 2021 and most recently edited on September 23rd 2022. 40 patients are needed across a dozen distinct sites."
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