Trials / Unknown
UnknownNCT05092815
The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
A Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX208 | HLX208 450mg bid po |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2024-06-30
- Completion
- 2024-10-30
- First posted
- 2021-10-26
- Last updated
- 2023-08-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05092815. Inclusion in this directory is not an endorsement.