Thrombocytopenia Associated With Chronic Liver DiseasePhase 3NCT07911800
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
A Phase 3 study testing rhTPO in people with Thrombocytopenia Associated With Chronic Liver Disease, run by MIBIO PTE. LTD. at 2 sites in Georgia.
Trial summary
This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia Associated With Chronic Liver Disease
- What is being tested?
- rhTPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesGeorgia
- Study dates
- 20 Oct 2026to 31 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 years of age at Screening.
- Subjects with CLDT who have baseline platelet count of <50 × 10⁹/L.
- Subjects scheduled to undergo a permitted elective invasive procedure must have an adequate pre-procedural platelet count.
- Subjects with Child-Pugh Class A or B.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of graded 0 or 1.
Who cannot join
- Any history of bone marrow diseases that interferes with platelet production.
- Current malignancy including solid tumors and hematologic malignancies (except HCC).
- History of liver transplantation, (partial) hepatic resection, splenectomy, splenic artery embolization, or transjugular intrahepatic portosystemic shunt (TIPS).
- Past or present thrombosis or prothrombotic condition.
- Presence of congenital or acquired thrombophilia or bleeding disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia2 sites, 1 recruiting
- Active, not recruiting
Caucasus Medical Center LLC
Tbilisi
- Recruiting
Geo Hospitals LLC
Tbilisi
995555499144, eimedashvili66@yahoo.com
About this study
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia in Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures
This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT). The study will evaluate rhTPO efficacy in elevating platelet level and its safety in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce pre-procedural platelet transfusion needs and the requirements for rescue treatment for bleeding.
- Being tested
- rhTPO, Placebo
- Keywords
- Thrombocytopenia, Chronic Liver Disease
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
For subcutaneous injection once daily, for up to 5 or 7 days
PlaceboDrug
For subcutaneous injection once daily, for up to 5 or 7 days
| Study group | Role | What they receive |
|---|---|---|
| Match placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| rhTPO | Experimental | Not described Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who require no platelet transfusion prior to the elective invasive procedure and no rescue therapy for bleeding.
Measured: 22 days
Secondary outcomes (2)
Proportion of subjects achieving the target platelet count from Baseline to Procedure Day before any platelet transfusion;
Measured: 8-15 days
Change in platelet count from Baseline to Pre-Procedural Assessment;
Measured: 8-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start20 Oct 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thrombocytopenia Associated With Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIBIO PTE. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911800
- Sponsor's protocol ID
- MIBIO-TPO-106-III-02
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No this kind of plan currently.
Publications
Han Y, Lin N, Xu J, Wang S, Jin J, Shang J, Xin Y, Tan Y, Zhang D, Hou J, An P, Xie W, Guan Y, Xiong Q, Wu H, Ding H, Chen Y, Li R, Wen Z, Lu M, Yang J, Zhou Z, Zhou Y, Yu Z, Lin K, Wang W, Huang Y, Nan Y, Luo X, Shi R, Kang Y, Han T, Chen S, Wang K, Shan Y, Li J, Liu P, Lu Z, Chen J, Liu Z, Zhang L, Yang L, Sheng J, Zeng Z, Yu Y, Xu X. Recombinant Human Thrombopoietin Reduces the Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Am J Hematol. 2026 Oct;101(10):2571-2580. doi: 10.1002/ajh.70444. Epub 2026 Jul 28.
PubMed 42517686
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia in Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures
- ClinicalTrials.gov ID
- NCT07911800
- Acronym / sponsor ID
- MIBIO-TPO-106-III-02
- Keywords
- Thrombocytopenia, Chronic Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MIBIO PTE. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT). The study will evaluate rhTPO efficacy in elevating platelet level and its safety in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce pre-procedural platelet transfusion needs and the requirements for rescue treatment for bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Match placebo | Placebo comparator | Drug: Placebo |
| rhTPO | Experimental | Drug: rhTPO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects ≥18 years of age at Screening.
- Subjects with CLDT who have baseline platelet count of <50 × 10⁹/L.
- Subjects scheduled to undergo a permitted elective invasive procedure must have an adequate pre-procedural platelet count.
- Subjects with Child-Pugh Class A or B.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of graded 0 or 1.
Key exclusion criteria (5 listed)
- Any history of bone marrow diseases that interferes with platelet production.
- Current malignancy including solid tumors and hematologic malignancies (except HCC).
- History of liver transplantation, (partial) hepatic resection, splenectomy, splenic artery embolization, or transjugular intrahepatic portosystemic shunt (TIPS).
- Past or present thrombosis or prothrombotic condition.
- Presence of congenital or acquired thrombophilia or bleeding disorders.
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 |
|---|---|---|
| rhTPOFor subcutaneous injection once daily, for up to 5 or 7 days | Drug | rhTPO |
| PlaceboFor subcutaneous injection once daily, for up to 5 or 7 days | Drug | Match placebo |
Primary outcome
Proportion of subjects who require no platelet transfusion prior to the elective invasive procedure and no rescue therapy for bleeding.
Time frame: 22 days
2 secondary outcomes
Proportion of subjects achieving the target platelet count from Baseline to Procedure Day before any platelet transfusion;
Time frame: 8-15 days
Change in platelet count from Baseline to Pre-Procedural Assessment;
Time frame: 8-14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 42517686Han Y, Lin N, Xu J, Wang S, Jin J, Shang J, Xin Y, Tan Y, Zhang D, Hou J, An P, Xie W, Guan Y, Xiong Q, Wu H, Ding H, Chen Y, Li R, Wen Z, Lu M, Yang J, Zhou Z, Zhou Y, Yu Z, Lin K, Wang W, Huang Y, Nan Y, Luo X, Shi R, Kang Y, Han T, Chen S, Wang K, Shan Y, Li J, Liu P, Lu Z, Chen J, Liu Z, Zhang L, Yang L, Sheng J, Zeng Z, Yu Y, Xu X. Recombinant Human Thrombopoietin Reduces the Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Am J Hematol. 2026 Oct;101(10):2571-2580. doi: 10.1002/ajh.70444. Epub 2026 Jul 28.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No this kind of plan currently.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhTPO in people with Thrombocytopenia Associated With Chronic Liver Disease, run by MIBIO PTE. LTD. at 2 sites in Georgia.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joe Wu (+65 66796282, joewu@3s-mibio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who require no platelet transfusion prior to the elective invasive procedure and no rescue therapy for bleeding. (time frame: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911800, which also lists 1 linked publication.
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 6 Nov 2026.