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An investigation of Recombinant Human Thrombopoietin (rhTPO) in management of chemotherapy induced thrombocytopenia

An investigation of Recombinant Human Thrombopoietin (rhTPO) in management of chemotherapy induced thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPB-15007591
Enrollment
Unknown
Registered
2015-12-15
Start date
2014-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma

Interventions

A:rhTPO 15000U injection everyday for 10 doses after chemotherapy
B:rhTPO 15000U injectioninjection at Day -4\-2\and day 2-9, total 10 doses.

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 70 years; 2. Histologically confirmed malignant tumor; 3. Will receive chemotherapy of high dose cytarabine (4g/m2/cycle) for at least 2 cycles; 4. ECOG PS score =2.0*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=100*10^9/L; (4) Serum total bilirubin <=1.5*ULN (upper limit of normal); (5) Serum AST and ALT <2.5*ULN; (6) Serum creatinine <=1.5*ULN; (8) INR <=1.5; 6. Give signed informed consent before enrollment.

Exclusion criteria

Exclusion criteria: 1. Severe internal bleeding or intracranial hemorrhage; 2. Allergy to any agent of the study medicines; 3. Withdraw origin treatment because of severe side effects; 4. Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events; 5. Neurological or mental abnormalities that may affect cognitive assessment and inform consent; 6. Other psychological, family or social reason, which the researcher think would affect compliance with the study protocol.

Design outcomes

Primary

MeasureTime frame
incidence of thrombocytopenia;

Secondary

MeasureTime frame
lasting time of thrombocytopenia;quantity of platelet transfusion;Safety profile;

Countries

China

Contacts

Public ContactTongyu Lin
tongyulin@hotmail.com+86 13926400320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026