Liver Disease ChronicPhase 1NCT05193201
A Phase Ib Clinical Study for rhTPO in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease
A Phase 1 study testing recombinant human thrombopoietin injection in people with Liver Disease Chronic and Thrombocytopenia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Disease Chronic, Thrombocytopenia
- What is being tested?
- recombinant human thrombopoietin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2022to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- There are currently patients with WHO ≥ Grade 2 active bleeding, or those with active bleeding in the past 2 weeks.
- Known human immunodeficiency virus positive or Treponema pallidum antibody positive.
- Combined with severe infections that cannot be effectively controlled (except for chronic hepatitis B and chronic hepatitis C).
- The subjects did not agree to take effective contraceptive measures during the trial period. The female subjects had a positive blood pregnancy test during the screening period; women who were pregnant or breastfeeding or had pregnancy plans within 3 months.
- Subjects' understanding, communication and cooperation are not enough to guarantee that the research will be carried out in accordance with the protocol.
- The researcher believes that the subjects are not suitable to participate in this study due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yimin Cui, PhD, 010-66110802, cuiymzy@126.com
Xiaoyuan Lin, Master, 010-83575787, xiaoyuanxu6@163.com
About this study
Official title: A Multicenter Phase Ib Clinical Study for Recombinant Human Thrombopoietin Injection in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease
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.
Read the 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.
- Conditions
- Liver Disease Chronic, Thrombocytopenia
- Being tested
- recombinant human thrombopoietin injection
- Keywords
- recombinant human thrombopoietin injection, Thrombocytopenia, Liver Disease Chronic
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human thrombopoietin injectionDrug
Also called rhTPO
recombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: recombinant human thrombopoietin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 8 days
Secondary outcomes (7)
the proportion of responders with platelet count
Based on the results of routine blood tests, calculate the proportion of responders with platelet counts during the study
Measured: Up to 36 days
Platelet count
Based on the results of routine blood tests, calculate the change in platelet count from baseline at different visit times after treatment. Calculate the duration of alleviation of thrombocytopenia symptom relief to different levels (≥50×10^9/L; ≥75×10^9/L; ≥100×10^9/L).
Measured: Up to 36 days
Platelet peak
Based on the results of routine blood tests, observe the peak value of platelets and record the peak time after treatment.
Measured: Up to 36 days
AE
All adverse events related to rhTPO observed through various tests (including blood routine, liver function, pregnancy test, electrocardiogram, etc.)
Measured: Up to 36 days
Immunogenicity of rhTPO
Detect the presence of anti-rhTPO antibodies through the subject's blood sample
Measured: At Day 1, Day 14, Day 36
Cmax
Detect the blood concentration of rhTPO by the subject's blood sample
Measured: Up to 36 days
AUC
Detect the blood concentration of rhTPO by the subject's blood sample, then calculate the area under the curve (AUC)
Measured: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start16 Jan 2022 (estimated)
- Primary completion16 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yimin Cui, PhD, Principal investigator, Peking University First HospitalXiaoyuan Lin, Master, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193201
- Sponsor's protocol ID
- 3SBio-TPO-106-Ib-01
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase Ib Clinical Study for Recombinant Human Thrombopoietin Injection in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05193201
- Acronym / sponsor ID
- 3SBio-TPO-106-Ib-01
- Conditions
- Liver Disease Chronic, Thrombocytopenia
- Keywords
- recombinant human thrombopoietin injection, Thrombocytopenia, Liver Disease Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2022 (estimated)
- Primary completion
- 16 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : 50*10^9/L ≤ Baseline of PLT < 75*10^9/L | Experimental | Drug: recombinant human thrombopoietin injectionThe 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. |
| Cohort 2 : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L. | Experimental | Drug: recombinant human thrombopoietin injectionThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human thrombopoietin injectionAlso: rhTPOrecombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days | Drug | Cohort 1 : 50*10^9/L ≤ Baseline of PLT < 75*10^9/L, Cohort 2 : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L. |
Primary outcome
the proportion of responders with platelet count
Time frame: Up to 8 days
Based on the results of routine blood tests, calculate the proportion of responders with platelet counts in the first 8 days after treatment
7 secondary outcomes
the proportion of responders with platelet count
Time frame: Up to 36 days
Platelet count
Time frame: Up to 36 days
Platelet peak
Time frame: Up to 36 days
AE
Time frame: Up to 36 days
Immunogenicity of rhTPO
Time frame: At Day 1, Day 14, Day 36
Cmax
Time frame: Up to 36 days
AUC
Time frame: Up to 36 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yimin Cui, PhD principal investigator
Peking University First Hospital
Xiaoyuan Lin, Master principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant human thrombopoietin injection in people with Liver Disease Chronic and Thrombocytopenia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Tong, MD (021-60970099, tonggang@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of responders with platelet count (time frame: Up to 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.