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Pegtibatinase for Homocystinuria
Study Summary
This trial is to test the efficacy and safety of Pegtibatinase in adult patients with CBS Deficiency-associated homocystinuria.
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 can become pregnant and will take pregnancy tests during the study.I have had an organ transplant, take immunosuppressants, or have a history of substance abuse.I haven't used any PEG-containing injectable drugs recently, except for pegtibatinase or COVID-19 vaccines.I haven't used any experimental drugs or devices in the last 30 days.I have previously been treated with or participated in a trial for pegtibatinase.I don't have any health issues or upcoming surgeries that would stop me from safely joining the study.I am scheduled for a major surgery during the study.I am willing to use birth control during and 4 weeks after the study.You are allergic to PEG-containing products or any parts of pegtibatinase.I have a genetic diagnosis of homocystinuria with high homocysteine levels.You have tested positive for HIV, hepatitis B, or hepatitis C.
- Group 1: Placebo
- Group 2: Pegtibatinase
- 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
Would this experiment include individuals who are elderly?
"The age range for this clinical trial is 12 to 65. There are 2 other trials available for minors and another 2 trials open to seniors."
Are there any available openings for patients who want to enroll in this research project?
"Yes, this trial is currently looking for participants. The clinicaltrials.gov website reports that the study was originally posted on 1/22/2019 and updated as recently as 7/11/2022."
How many research subjects will be enrolled in this trial?
"That is correct, the online information does show that this study is recruiting patients. The trial was first posted on 1/22/2019 and has since been edited on 7/11/2022. They are looking for a total of 32 patients that will be recruited from 7 sites."
In how many different locations is this trial being run today?
"Presently, this experiment is being conducted at 7 sites. The locations are situated in Miami, Philadelphia and Indianapolis with 4 other cities also hosting a location. If you want to limit travel, it would be best to select a site near your residence."
Can I join this clinical trial?
"This study is looking for 32 participants with homocystinuria who fall between the ages of 12 and 65. The most important criteria that candidates must meet are as follows: They must be able to provide written consent, they must be willing to comply with all procedures related to the study, they must be sexually active or have sexually active partners, and they must be willing to use contraception while on the study. Additionally, subjects who identify as female but were born biologically male do not need to undergo pregnancy tests. Lastly, all participants must be willing to maintain a stable diet and complete a daily diet diary."
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