NCT05193201

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 31, 2021

Last Update Submit

December 31, 2021

Conditions

Liver Disease ChronicThrombocytopenia

Keywords

recombinant human thrombopoietin injectionThrombocytopeniaLiver Disease Chronic

Outcome Measures

Primary Outcomes (1)

  • the proportion of responders with platelet count

    Based on the results of routine blood tests, calculate the proportion of responders with platelet counts in the first 8 days after treatment

    Up to 8 days

Secondary Outcomes (7)

  • the proportion of responders with platelet count

    Up to 36 days

  • Platelet count

    Up to 36 days

  • Platelet peak

    Up to 36 days

  • AE

    Up to 36 days

  • Immunogenicity of rhTPO

    At Day 1, Day 14, Day 36

  • +2 more secondary outcomes

Study Arms (2)

Cohort 1 : 50*10^9/L ≤ Baseline of PLT < 75*10^9/L

EXPERIMENTAL

The multiple-dose regimen (15000 U subcutaneous injection once a day for 7 days) of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.

Drug: recombinant human thrombopoietin injection

Cohort 2 : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L.

EXPERIMENTAL

The multiple-dose regimen (15000 U subcutaneous injection once a day for 7 days) of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.

Drug: recombinant human thrombopoietin injection

Interventions

recombinant human thrombopoietin injectionDRUG

recombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days

Also known as: rhTPO
Cohort 1 : 50*10^9/L ≤ Baseline of PLT < 75*10^9/LCohort 2 : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: There is no limit to men and women.
  • 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.

You may not qualify if:

  • 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.
  • Use heparin, warfarin, non-steroidal anti-inflammatory drugs, aspirin, verapamil, and ticlopidine or glycoprotein IIb/IIIa antagonist (such as tirofiban) within 7 days before administration treat.
  • Interferon has been used within 14 days before administration.
  • Have received platelet transfusion or used platelet-containing blood products within 14 days before administration, except for transfusion of concentrated red blood cells.
  • Those who have received any platelet-increasing therapy within 28 days before administration (the platelet-increasing function of Li Kejun, caffeic acid tablets and/or certain Chinese medicines or Chinese patent medicines that have the function of increasing platelet function can be accepted within 14 days), including but not Limited to rhTPO.
  • No more than 28 days after the cessation of other research drug treatments or device research treatments carried out before the administration.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yimin Cui, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaoyuan Lin, Master

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Tong, MD

CONTACT

021-60970099tonggang@3sbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

January 16, 2022

Primary Completion

October 16, 2022

Study Completion

December 31, 2022

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)