Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Recruiting
Phase 3
Interventional Study
Plexiform Neurofibroma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 177 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
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About This Trial
This study aims to demonstrate that in subjects with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, TQ-B3234 capsules significantly improve the objective response rate at Week 24 compared to placebo.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* The subject voluntarily joins this study, signs the informed consent form, and demonstrates good compliance.
* Age ≥18 years (calculated from the date of signing the informed consent form).
* Diagnosis of symptomatic, non-resectable neurofibromatosis type 1 (NF1)-associated pl…
Contacts