Trials / Completed
CompletedNCT04361279
A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL
A Phase III, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of SIBP-02 (Rituximab Biosimilar) and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- Shanghai Institute Of Biological Products · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China. In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SIBP-02 | Injection，100mg/10ml |
| DRUG | Rituximab | Injection，100mg/10ml |
Timeline
- Start date
- 2019-07-25
- Primary completion
- 2022-05-20
- Completion
- 2022-05-20
- First posted
- 2020-04-24
- Last updated
- 2023-12-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04361279. Inclusion in this directory is not an endorsement.