This trial is active, not recruiting.

Condition thrombocytopenia
Phase phase 4
Sponsor Shenyang Sunshine Pharmaceutical Co., LTD.
Start date May 2009
End date June 2015
Trial size 120 participants
Trial identifier NCT02344979, ShenyangSunshine


Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Patients were treated with recombinant human thrombopoietin(rHuTPO)on d2,d4,d6,d9 of chemotherapy cycle.
Patients were treated with recombinant human interleukin-11(rHuIL-11)on d9-d15 after chemotherapy.

Primary Outcomes

The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
time frame: 28days

Secondary Outcomes

The time to achieve platelet count ≥75×109/L and ≥100×109/L after rHuTPO or rHuIL-11. The duration of platelet count <50×109/L after rHuTPO or rHuIL-11.
time frame: 28days
The number of platelet transfusions after rHuTPO or rHuIL-11.
time frame: 28days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age>18 years, Male or females - Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin - Platele counts ≤ 50×109/L during Screening chemo cycle - ECOG PS score is ≤ 2 - The predicted life expectancy ≥3 months - Written informed consent Exclusion Criteria: - Pregnant or nursing women - Known history of severe anaphylactic reaction to biologics - Uncontrolled severe infection - History of bone or central nervous system metastasis - History of platelet disorder - Active bleeding

Additional Information

Official title The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC Receiving Gemcitabine and Cisplatin or Carboplatin Chemotherapy
Description Inclusion Criteria: 1. Patients aged 18 years -75 years, male or female; 2. histologically or cytologically confirmed non-small cell lung cancer; 3. consistent with the indication of chemotherapy 4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L; 5. the expected survival was more than 3 months; 6. patients must have the ability to understand and the willingness to sign a written informed consent; 7. to be able to follow the study and follow-up procedures Exclusion Criteria: 1. pregnant or lactating women; 2. patients who had severe allergic history on biological preparation; 3. the existing serious acute infection without control; 4. Patients receiving radiotherapy; 5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 * 109/ L on the screening period on the seventeenth day of the screening period; 6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months; 7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy; 8. tumor metastasis was found in the central nervous system;
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Shenyang Sunshine Pharmaceutical Co., LTD..