ThrombocytopeniaNCT02344979
The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC
An observational study of Thrombocytopenia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin,and Platele counts ≤ 50×109/L during Screening chemo cycle
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Inclusion Criteria:
- Patients aged 18 years -75 years, male or female;
- histologically or cytologically confirmed non-small cell lung cancer;
- consistent with the indication of chemotherapy
- the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;
- the expected survival was more than 3 months;
- patients must have the ability to understand and the willingness to sign a written informed consent;
- to be able to follow the study and follow-up procedures
Exclusion Criteria:
- pregnant or lactating women;
- patients who had severe allergic history on biological preparation;
- the existing serious acute infection without control;
- Patients receiving radiotherapy;
- 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;
- with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;
- Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;
- tumor metastasis was found in the central nervous system;
- Conditions
- Thrombocytopenia
- Keywords
- NSCLC, Chemotherapy, thrombocytopenia, rhTPO
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group rHuTPO | Patients were treated with recombinant human thrombopoietin(rHuTPO)on d2,d4,d6,d9 of chemotherapy cycle. | |
| Group rHuIL-11 | Patients were treated with recombinant human interleukin-11(rHuIL-11)on d9-d15 after chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
Measured: 28days
Secondary outcomes (2)
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.
Measured: 28days
The number of platelet transfusions after rHuTPO or rHuIL-11.
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMay 2009
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344979
- Sponsor's protocol ID
- ShenyangSunshine
- Status last verified
- Jan 2015
- First submitted
- 18 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02344979
- Acronym / sponsor ID
- ShenyangSunshine
- Conditions
- Thrombocytopenia
- Keywords
- NSCLC, Chemotherapy, thrombocytopenia, rhTPO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion Criteria:
- Patients aged 18 years -75 years, male or female;
- histologically or cytologically confirmed non-small cell lung cancer;
- consistent with the indication of chemotherapy
- the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;
- the expected survival was more than 3 months;
- patients must have the ability to understand and the willingness to sign a written informed consent;
- to be able to follow the study and follow-up procedures
Exclusion Criteria:
- pregnant or lactating women;
- patients who had severe allergic history on biological preparation;
- the existing serious acute infection without control;
- Patients receiving radiotherapy;
- 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;
- with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;
- Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;
- tumor metastasis was found in the central nervous system;
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group rHuTPO | – | –Patients were treated with recombinant human thrombopoietin(rHuTPO)on d2,d4,d6,d9 of chemotherapy cycle. |
| Group rHuIL-11 | – | –Patients were treated with recombinant human interleukin-11(rHuIL-11)on d9-d15 after chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin,and Platele counts ≤ 50×109/L during Screening chemo cycle
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
Time frame: 28days
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11. (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.