Trials / Completed
CompletedNCT05220878
Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- AO GENERIUM · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura
Detailed description
The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register of the drug GNR-069 in the Russian Federation for therapy in patients with idiopathic thrombocytopenic purpura (ITP). The study also provides for the evaluation of pharmacokinetic parameters and immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GNR-069 | Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg. |
| BIOLOGICAL | Nplate | Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg. |
Timeline
- Start date
- 2021-09-09
- Primary completion
- 2023-08-22
- Completion
- 2023-10-19
- First posted
- 2022-02-02
- Last updated
- 2024-03-06
Locations
18 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05220878. Inclusion in this directory is not an endorsement.