Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 years or above, gender not restricted;
Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10^9/L, defined as refractory CTIT);
Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
Patients with platelet count at enrollment < 30×10^9/L;
Disqualifiers
Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
Patients with poor compliance;
Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
Trial design
Design model
Single group
Treatments tested in this trial
Romiplostim N01
DrugThe subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Romiplostim N01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficiency after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 50 × 10\^9/L after 12 weeks (3 months) of treatment with Romiplostim N01.
Time frame
12 weeksSecondary outcomes
1
Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10\^9/L or ≥ 100×10\^9/L after 12 weeks (3 months) of treatment with Romiplostim N01
Time frame
12 weeks2
Efficiency after 24 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10\^9/L, ≥ 50×10\^9/L, or ≥ 100×10\^9/L after 24 weeks (6 months) of treatment with Romiplostim N01
Time frame
24 weeks3
Platelet counts at each visit point
Platelet counts after the treatment of Romiplostim N01 at each visit point
Time frame
24 weeks4
WHO bleeding scale at each visit point
Changes of the WHO bleeding scale after the treatment of Romiplostim N01 at each visit point. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
Tianjin Third Central Hospital
Collaborator
Tianjin People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov