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Long-Term Follow-Up of Subjects Treated With NTLA-2001
EU CTIS ID: 2023-507385-11-00
What this study is testing
To evaluate the long-term safety of NTLA-2001 in previously treated participants
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. A participant has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received.
- 2. A participant has provided informed consent for the LTFU study.
- 3. A participant is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements.
- 4. Male participants must agree to the following until 4 months after the last administration of study intervention in the parent study: a. Refrain from donating sperm. The time frame may be extended beyond 4 months if sperm donation is contraindicated based on country-specific guidelines. AND b. Use a male condom, in addition to the female partner using a highly effective contraceptive method with a failure rate of < 1% per year, when having sexual intercourse with a WOCBP (Section 10.3.1).
- 5. Female participants must agree to the following until 7 months after the last administration of study intervention in the parent study: a. Use a protocol-specified highly effective method of contraception, if a WOCBP. This is not required for female participants who are postmenopausal or surgically sterile, as defined in Section 10.3.1. AND b. Not undergo oocyte retrieval for in vitro fertilization for at least 7 months after the last administration of study intervention. The time frame may be extended beyond 7 months if oocyte retrieval is contraindicated based on country-specific guidelines.
You likely can't join if
- None.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.