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RNAi
SLN124 for Polycythemia Vera (SLN Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Silence Therapeutics plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months prior to dosing to day 239
Awards & highlights
SLN Trial Summary
This trial is testing a new drug for Polycythemia Vera, to see if it's safe, how it affects the body and how well it works.
Who is the study for?
Adults with Polycythemia Vera (PV) who've had a skin check in the last 6 months, meet specific PV diagnostic criteria, and have stable phlebotomy history. They must not be on or have recently used certain drugs for PV, agree to contraception, and have an acceptable level of physical functioning.Check my eligibility
What is being tested?
The study is testing SLN124 against a placebo in patients with PV. It starts with an open-label phase where everyone gets SLN124 to find safe doses, followed by a randomized phase where participants are blindly given either SLN124 or a placebo to compare effects.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site due to intolerance to components in SLN124 or GalNAc conjugates. Other risks may involve liver issues and blood disorders since eligibility excludes those with significant liver disease or abnormal blood counts.
SLN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months prior to dosing to day 239
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months prior to dosing to day 239
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the number of phlebotomies at intervals
Incidence of treatment-emergent adverse events (AEs)
Secondary outcome measures
Pharmacodynamic: Change in Hepcidin
Pharmacodynamic: Change in Transferrin saturation (TSAT)
Body Weight Changes
+2 moreSLN Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2 Blinded SLN124Experimental Treatment1 Intervention
SLN124 for subcutaneous (s.c.) injection
Group II: Phase 1 open-label SLN124Experimental Treatment1 Intervention
SLN124 for subcutaneous (s.c.) injection
Group III: Phase 2 Blinded PlaceboPlacebo Group1 Intervention
Sodium chloride for s.c. injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLN124
2020
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Silence Therapeutics plcLead Sponsor
5 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have seen a skin doctor in the last 6 months.I have had major bleeding or needed a blood transfusion due to bleeding in the last 6 months.My condition meets the international criteria for post-PV myelofibrosis.I have been diagnosed with polycythemia vera according to the latest criteria.I am 18 years old or older.I've been on a stable dose of specific cancer treatment for at least 12 weeks with no changes planned.I can take care of myself and am up and about more than half of my waking hours.I have not had a significant blood clot in the last 3 months.I stopped my cancer-shrinking treatment 24 weeks ago and have recovered from its side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Blinded Placebo
- Group 2: Phase 1 open-label SLN124
- Group 3: Phase 2 Blinded SLN124
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaged in this experiment?
"Indeed, the information on clinicaltrials.gov suggests that this research project is actively enrolling patients. It was first published on January 1st 2023 and has since been edited as recently as December 1st of the same year. The trial requires 65 participants to be recruited from 2 different locations."
Answered by AI
Does this clinical experiment currently have any vacancies?
"Affirmative, the information available on clinicaltrials.gov reports that this particular medical trial is currently enlisting patients. This project was first posted to the platform in January 1st 2023 and has had subsequent revisions up until December 1st of the same year. With two different sites open for enrollment, 65 people are needed to complete it."
Answered by AI
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