Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorBeijing Tongren Hospital
About this trial
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
Eligibility criteria
Qualifiers
Age ≥14 years old, male or female;
Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
Abnormal (mental) behavior or cognitive dysfunction
Speech dysfunction (verbal urgency, hypospeech, mutism)
Disqualifiers
History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
Currently have active hepatitis or have severe liver disease and a history of it.
Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included.
Trial design
Treatments tested in this trial
- Taitacept
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov