Clinical trial · Interventional
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
NCT01919710CI-TRIAL-00018126completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
| Underdose (Unintentional) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rHSA/GCSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rHSA/GCSF for injection
- description
- rHSA/GCSF Start from 300mcg
- interventionNames
- Drug: rHSA/GCSF
Primary outcomes (1)
- measure
- Number of adverse events
- timeFrame
- 14 days
- description
- Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
Secondary outcomes (1)
- measure
- AUC
- timeFrame
- 14 days
- description
- AUC after single and multiple dose of rHSA/GCSF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: \- chemotherapy induced neutropenia Exclusion Criteria: \- treated with other biological drugs or other neutropenia therapy drugs
References
Publications (0)
Data not yet available
No reference posted for this study.