Trials / Unknown
UnknownNCT02456207
A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
A Phase II, Multi-center, Randomized and Open Study to Evaluate and Compare the PK, PD and Safety of SCT400 With Rituximab in Patients With CD20+ B-cell Non-Hodgkin's Lymphoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCT400 | |
| DRUG | Rituximab |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2015-05-28
- Last updated
- 2015-05-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02456207. Inclusion in this directory is not an endorsement.