Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Chemotherapy-Induced Thrombocytopenia Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag in Subjects With Chemotherapy-induced Thrombocytopenia Receiving Chemotherapy for the Treatment of Solid Tumors.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03976882
• Other study ID #: HR-TPO-CIT-III
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 6, 2019
• Est. completion date: March 15, 2024

Study information

• Verified date: August 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: March 15, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Men and women, 18-75 years of age;

2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen;

3. Participant experienced thrombocytopenia and chemotherapy delay;

4. ECOG performance status 0-1;

Exclusion Criteria:

1. Screening and baseline platelet count< 30×109/L;

2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;

3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;

4. Participant has serious bleeding symptoms;

5. Participant has no hepatic metastases, ALT/AST>3ULN, TBIL>3ULN; with hepatic metastases, ALT/AST=5ULN, TBIL=5ULN;

6. Blood Cr=1.5ULN or eGFR=60 ml/min(Cockcroft-Gault);

7. History of allergy to the study drug;

8. Participant with HIV;

9. Pregnant or lactating women;

10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Related Conditions & MeSH terms

• Chemotherapy-Induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Hetrombopag
Hetrombopag
• Placebo
Placebo

Locations

Country	Name	City	State
China	Najing Bayi Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of treatment responders.		Randomization up to 90 days
Secondary	Duration from starting treatment to initiating chemotherapy and platelet count =100×109/L		Randomization up to 30 days
Secondary	Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification		Randomization up to 150 days
Secondary	Proportion of subjects without serious bleeding event		Randomization up to 180 days
Secondary	Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0		Randomization up to 180 days