Trials / Unknown
UnknownNCT06178146
Thymosin Alpha-1 for irAE Secondary to ICIs
A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Jun Wang · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Thymosin Alpha1 | Based on the conventional treatment, subcutaneous injection of Tα-1 (1.6 mg, qd) in Week 1; and in Week 2, subcutaneous injection of thymalfasin 1.6 mg, 3 times a week, followed by twice a week for 1 month since Week 3. |
| DRUG | Immunosuppressant | Grade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted. |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-11-01
- Completion
- 2025-04-01
- First posted
- 2023-12-20
- Last updated
- 2023-12-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06178146. Inclusion in this directory is not an endorsement.