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Coversin for Paroxysmal Nocturnal Hemoglobinuria (CONSENTII Trial)
CONSENTII Trial Summary
This trial is testing the effectiveness of a new drug, Coversin, in patients with a blood disorder who have been resistant to treatment with a different drug, Eculizumab.
CONSENTII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCONSENTII Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 1 Patients • NCT02591862CONSENTII Trial Design
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Who is running the clinical trial?
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- I have not been fully vaccinated against meningitis.Your LDH levels are higher than the normal range.My weight is either below 50 kg (110 lb) or above 100 kg (220 lb).I have been diagnosed with PNH.I am 18 years old or older.I am willing to give myself daily injections of Coversin.My kidney function is not normal.I currently have an untreated meningitis infection.My condition did not improve with Soliris treatment.You have a severe allergic reaction to ticks or insect stings.My liver isn't working properly.The study leader does not consider me fit for the trial for other reasons.I am willing to take preventive treatment against Neisseria infection.
- Group 1: Coversin treatment
- 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
How many participants is the upper limit of this investigation?
"This clinical trial is no longer accepting participants. It was posted on May 14th 2018, and saw its last update occur on June 21st 2022. If you are looking to join other trials related to hemoglobinuria, there are currently 31 studies recruiting volunteers; Coversin-centric research has two active recruitment drives as well."
Has a comparable experiment ever been conducted before?
"The exploration of Coversin started in 2018, when AKARI Therapeutics ran a pilot study with 6 participants. Subsequently, Phase 2 approval was granted and now there are two live trials for the drug taking place across 5 cities and 3 nations."
Has Coversin been evaluated in any other research studies?
"Presently, there are two extant clinical trials examining Coversin with one of them in its final phase. Most studies for this medication occur in New york City but additional sites exist across the country."
Is enrollment for this experiment still available to participants?
"Contrary to what is posted on clinicaltrials.gov, this medical trial has ceased patient recruitment at the time of writing. It was first published in May 14th 2018 and most recently edited June 21st 2022; nonetheless there are still 33 other studies actively seeking participants."
Is Coversin considered a reliable therapeutic option?
"The safety profile of Coversin was ranked as a 2, since there is information affirming its security but no clinical data suggesting efficacy."
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