Skip to content

A randomized control trial of prophylactic application of recombinant human thrombopoietin (rhTPO) for thrombocytopenia caused by high-dosed chemotherapy

A randomized control trial of prophylactic application of recombinant human thrombopoietin (rhTPO) for thrombocytopenia caused by high-dosed chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000433
Enrollment
Unknown
Registered
2009-06-04
Start date
2007-08-01
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

Thrombocytopenia caused by high-dosed chemotherapy

Interventions

None listed

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. In-patiants with malignant solid tumor proved by histopathology or Cytology; 2. general state of health is good. ECOG Performance Status months; 3. Male and female aged 18 to 70 years old; 4. Chemotherapy interval >=4 weeks from the last radiation therapy or isotope treatment; count of blood cell before treatment should in following range: WBC 4.0*10^9/L to 10*10^9/L, Hb 95g/L to 165g/L, PlT 75*10^9/L to 300*10^9/L; 5. Liver and kidney function are normal; Electrocardiogram is normal; 6. Patients will receive 2 periods equally high-dosed chemotherapy; 7. Patients with good compliance and accepting follow-up; 8. Inform of consents were signed voluntarily.

Exclusion criteria

Exclusion criteria: 1. Hb<60g/L; 2. Active bleeding; 3. History of thromboembolic disease and congestive heart disease; 4. Pregnant or lactated women; 5. Patients taking oral conceptive drugs or estrin treatment after menopause; 6. Patients with bone marrow dysplasia or severe cerebrovascular disease; 7. Brain metastases that affect patients describing the state of illness; 8. Patients with hypersensitive constitution or allergy to rhTPO; 9. Patients having operation in last 2 weeks or chemotherapy or radiotherapy in last 4 weeks.

Design outcomes

Primary

MeasureTime frame
Platelets infusion amount and rate;

Secondary

MeasureTime frame
Extreme value of count of platelets and it's change;Rate of hemorrhage activity;Mean of count of platelet at different time point;Thrombocytopoiesis rate and duration;

Contacts

Public ContactLijun Di, Jun Ren
dilijun2006@yahoo.com+86 010 8819 6406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026