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Vamifeport for Sickle Cell Disease (ViSionSerenity Trial)
Phase 2
Waitlist Available
Research Sponsored by Vifor (International) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential
Body weight ≥40 kg and ≤120 kg at screening and baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks of treatment
Awards & highlights
ViSionSerenity Trial Summary
This trial is testing a new drug to see if it can help treat sickle cell disease by reducing the breakdown of red blood cells. They will also be testing for safety and side effects.
Who is the study for?
This trial is for men and women with confirmed sickle cell disease (HbS/S or HbS/βT0 genotype). Participants must have had 1-10 pain crises in the past year, weigh between 40-120 kg, and if sexually active, agree to use contraception. Exclusions include recent hospitalization for SCD events, certain liver diseases, cardiac/pulmonary disorders, infections requiring therapy, hormonal contraceptive use within 4 weeks prior to screening among others.Check my eligibility
What is being tested?
The study tests VIT-2763 (Vamifeport) at different doses (120 mg BID, 240 mg TID, and 360 mg TID) against a placebo to see its effects on red blood cell breakdown in sickle cell disease. It also assesses safety and potential benefits of the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns may include digestive issues due to oral medication intake; potential risks associated with altered liver enzymes; reactions related to anemia management like fatigue or dizziness; and possible complications from long-term organ inflammation.
ViSionSerenity Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man who will not have sex or will use a condom with women who can get pregnant.
Select...
My weight is between 40 kg and 120 kg.
Select...
I have sickle cell disease with either HbS/S or HbS/βT0 genotype.
ViSionSerenity Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Frequency and severity of reported or observed adverse events (AEs)
Mean change from baseline in haemolysis markers
ViSionSerenity Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3Experimental Treatment1 Intervention
Participants receive VIT-2763 120 mg, three times a day during 8 weeks.
Group II: Cohort 2Experimental Treatment1 Intervention
Participants receive VIT-2763 120 mg, twice a day during 8 weeks.
Group III: Cohort 1Experimental Treatment1 Intervention
Participants receive VIT-2763 60 mg, twice a day during 8 weeks.
Group IV: Cohort 4bPlacebo Group1 Intervention
Participants receive a placebo, three times a day during 8 weeks.
Group V: Cohort 4aPlacebo Group1 Intervention
Participants receive a placebo, twice a day during 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIT-2763 120 mg
2021
Completed Phase 2
~30
VIT-2763 360 mg
2021
Completed Phase 2
~30
VIT-2763 240 mg
2021
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Fortrea, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
512 Total Patients Enrolled
FortreaIndustry Sponsor
9 Previous Clinical Trials
2,395 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who will not have sex or will use a condom with women who can get pregnant.I am not pregnant, not breastfeeding, and will use birth control or abstain from sex.My weight is between 40 kg and 120 kg.My hemoglobin level is within the required range for my gender.I was hospitalized for sickle cell disease events within the last 14 days.I have chronic liver disease or a history of liver cirrhosis.I have been recently diagnosed with a significant folate deficiency anemia.My family has a history of sudden death or long-QT syndrome without known causes.I cannot take or absorb pills.I have had a blood transfusion in the last 4 weeks or will need one during the study.I have bleeding that cannot be controlled.I have a history of heart or lung problems.My kidney function is low or I am on chronic dialysis.I have been on a stable dose of hydroxyurea for at least 3 months.I have sickle cell disease with either HbS/S or HbS/βT0 genotype.I had between 1 and 10 pain crises due to sickle cell in the last year.I am currently being treated for a serious infection.I am not using certain hormonal contraceptives as per the study's rules.I have no other cancers except skin, early-stage cervical or breast cancer, or incidental prostate cancer in the last 2 years.I had a stomach or duodenal ulcer in the last 6 months or it healed after 3 months of treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4b
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 3
- Group 5: Cohort 4a
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.
Are researchers currently enrolling participants in this trial?
"The data from clinicaltrials.gov reveals that this trial is currently recruiting patients, having been published on June 9th 2021 and most recently updated on November 15th 2022."
Answered by AI
How many North American healthcare facilities are administering this research?
"For this particular trial, patients are being recruited at Investigator Site 703 in Chicago, IL; Investigator Site 702 in Milwaukee, WI and Investigator Site 701 in Greenville, NC. Additionally 6 other sites have been approved for participation."
Answered by AI
Is admission to this trial open for my participation?
"This clinical trial requires anemic individuals with sickle cell and aged between 18 to 60 years old. The total number of study participants needed is 24."
Answered by AI
Can individuals aged 35 and over join this clinical experiment?
"This medical trial only permits patients aged 18 to 60. Those under the age of consent can find 131 other trials available, while those above 65 have 85 options to choose from."
Answered by AI
Can you elucidate the potential harms associated with VIT-2763?
"The safety of VIT-2763 was given a score of 2, as this is an early stage clinical trial with evidence contending its safety but no data demonstrating efficacy."
Answered by AI
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