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Lenti-D for Adrenoleukodystrophy
Study Summary
This trial will enroll males with CALD who are less than or equal to 17 years old. The trial will be open-label, meaning that both the participants and the study staff will know which participants are receiving the Lenti-D Drug Product. The trial will be conducted at multiple sites internationally. Approximate 35 participants will be infused with Lenti-D Drug Product.
- Adrenoleukodystrophy (ALD)
Timeline
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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- You have previously received a transplant from another person or have undergone gene therapy treatment.You are allergic to protamine sulfate.You have a condition that prevents you from having an MRI scan, such as allergies to anesthesia or contrast agents.Someone in your close family has a known or suspected genetic condition that increases the risk of cancer.You are currently taking statins, Lorenzo's Oil, or following a special diet to lower certain levels in your body. You will need to stop taking these medications or following the diet if you want to participate in the study.You have any serious heart, blood, lung, or other health condition that would make it unsafe for you to participate in the study procedures.
- Group 1: Lenti-D Drug Product
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any available vacancies for participants in this experiment?
"Unfortunately, this specific clinical trial is not currently looking for patients. Although the last update to the postings was on March 22nd, 2022, it is possible that the study will begin searching for participants again in the future. As of right now, there are 14 other trials that are actively enrolling patients."
Are there any dangers to using Lenti-D for treatment?
"Lenti-D has received a score of 3 for safety. This is due to the fact that it is a phase 3 trial, meaning there are multiple rounds of data supporting efficacy and safety."
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