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A Phase Ib Clinical Study for rhTPO in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE1

A Phase Ib Clinical Study for rhTPO in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

A Multicenter Phase Ib Clinical Study for Recombinant Human Thrombopoietin Injection in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

NCT05193201•Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

The purpose of this study is to explore the multiple-dose regimen of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.

Detailed Description

This is a multi-center, open label, phase Ib clinical study. The effectiveness of the multiple-dose regimen of recombinant human thrombopoietin injection in the treatment of thrombocytopenia in patients with chronic liver disease is mainly verified by evaluating the proportion of responders with platelet count in the first 8 days after treatment. Cohort 1 (n=18) : 50\*10\^9/L ≤ Baseline of PLT \< 75\*10\^9/L. Cohort 2 (n=36) : 30\*10\^9/L ≤ Baseline of PLT \< 50\*10\^9/L.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Gender: There is no limit to men and women.
•18 years old to 75 years old.
•Liver cirrhosis diagnosed by biopsy/imaging due to chronic liver disease, and Child-Pugh classification is A and B. Patients with liver cirrhosis diagnosed by transient elastography technology can also be included in the group.
•Baseline platelet level: 30×10\^9/L≤platelet count\<75×10\^9/L.
•Liver function ALT and aspartate aminotransferase (AST)≤5×ULN, total bilirubin≤1.5×ULN, blood creatinine≤1.5×ULN.
•Able to understand and be willing to comply with the requirements of the clinical trial protocol, and voluntarily sign a written informed consent form.

Exclusion Criteria

•Those who are known to be allergic to any component of this product.
•Patients with liver cirrhosis caused by drug-induced liver damage.
•Those with a history of splenectomy or liver transplantation.
•Previously or currently suffering from serious diseases of any organ or system other than the liver, including cardiovascular disease, blood system disease, and nervous system disease patients, as well as any other diseases judged by the investigator to be unsuitable for participating in this trial.
•Currently suffering from malignant tumors, including solid tumors and hematological malignancies.
•Those who are clearly diagnosed as liver failure.
•Liver cirrhosis with serious complications, including: hepatic encephalopathy, refractory ascites, upper gastrointestinal bleeding, etc.;.
•People who have previously or are currently suffering from any disease that may lead to reduced platelet count and/or abnormal platelet function except for chronic liver disease and cirrhosis, including aplastic anemia, myelodysplastic syndrome, myelofibrosis, etc.
•Those who have undergone intrahepatic portosystemic shunt via jugular vein in the past.
•Doppler ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI) and other imaging examinations that indicate the presence of portal vein thrombosis within 28 days before administration.
+11 more criteria

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 16, 2022

Primary Completion Date

October 16, 2022

Completion Date

December 31, 2022

Last Updated

January 14, 2022

Enrollment

ESTIMATED participants

Conditions

Liver Disease ChronicThrombocytopenia

Interventions

recombinant human thrombopoietin injection

DRUG

Contacts

Gang Tong, MD

CONTACT

021-60970099 tonggang@3sbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase Ib Clinical Study for rhTPO in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

Inclusion Criteria

Exclusion Criteria

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

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