Health TrialsbyHealthPanel

Herombopag for Chemotherapy-induced Thrombocytopenia

ConditionsChemotherapy-induced ThrombocytopeniaHerombopag
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 Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years old, male or female;

Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；

Stop radiotherapy or chemotherapy for more than 1 month;

Platelet counts <30 ×10^9/L, and bleeding tendency;

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

  • Herombopag

    Drug

    The subjects will initiate treatment with 7.5 mg/d Herombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 7.5 mg daily. Subjects whose platelet count ≤100×109/L，the Herombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of Herombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of Herombopag to 2.5mg once every other day or lower frequency during the treatment period, Herombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Herombopag if the platelet is greater than 50×109/L.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: 50 subjects with chemotherapy-induced thrombocytopeniaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes of the platelet counts after the treatment of Herombopag at week 12

The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10\^9/L ， 50 × 10\^9/L and 100 × 10\^9/L at week 12.

Time frame
12 weeks
2

Changes of the platelet counts after the treatment of Herombopag at week 24

The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10\^9/L ， 50 × 10\^9/L and 100 × 10\^9/L at week 24.

Time frame
24 weeks

Secondary outcomes

1

Incidence of adverse events after the treatment of Herombopag

The investigator will observe incidence of adverse events after the treatment of Herombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.

Time frame
24 weeks
2

Changes of concentration of TPO in peripheral blood

The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Herombopag, if necessary.

Time frame
24 weeks
3

Changes of concentration of TPO antibodies，anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood

The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Herombopag, if necessary

Time frame
24 weeks

Other outcomes

Sponsors 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
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