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RecruitingNCT07911800Updated Nov 3, 2026

Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.

A Phase 3 interventional study of rhTPO and Placebo in Thrombocytopenia Associated With Chronic Liver Disease, sponsored by MIBIO PTE. LTD.. Recruiting at 2 sites in Georgia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by MIBIO PTE. LTD. · Phase 3, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Thrombocytopenia Associated With Chronic Liver Disease

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Keywords

  • Chronic Liver Disease, Thrombocytopenia
03

In context

Thrombocytopenia

705 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 150 is above the median of 54 across 477 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

This is the only study on the registry with MIBIO PTE. LTD. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects ≥18 years of age at Screening.
  2. Subjects with CLDT who have baseline platelet count of \<50 × 10⁹/L.
  3. Subjects scheduled to undergo a permitted elective invasive procedure must have an adequate pre-procedural platelet count.
  4. Subjects with Child-Pugh Class A or B.
  5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of graded 0 or 1.

Exclusion criteria

Exclusion Criteria:

  1. Any history of bone marrow diseases that interferes with platelet production.
  2. Current malignancy including solid tumors and hematologic malignancies (except HCC).
  3. History of liver transplantation, (partial) hepatic resection, splenectomy, splenic artery embolization, or transjugular intrahepatic portosystemic shunt (TIPS).
  4. Past or present thrombosis or prothrombotic condition.
  5. Presence of congenital or acquired thrombophilia or bleeding disorders.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Match placebo

    Drug: Placebo

  • Experimental
    rhTPO

    Drug: rhTPO

Interventions

  • DrugrhTPO

    For subcutaneous injection once daily, for up to 5 or 7 days

  • DrugPlacebo

    For subcutaneous injection once daily, for up to 5 or 7 days

06

What researchers measure

Primary outcomes

  1. Proportion of subjects who require no platelet transfusion prior to the elective invasive procedure and no rescue therapy for bleeding.

    Time frame: 22 days

Secondary outcomes

  1. Proportion of subjects achieving the target platelet count from Baseline to Procedure Day before any platelet transfusion;

    Time frame: 8-15 days

  2. Change in platelet count from Baseline to Pre-Procedural Assessment;

    Time frame: 8-14 days

07

Study locations

1 of 2 sites recruiting
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: No — No this kind of plan currently.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Oct 2028, 24 months after the start.

Of 26 industry-sponsored phase 3 interventional studies under Thrombocytopenia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 38. This study's planned 24 months is close to that.

Counting every sponsor, half of 43 studies reached it within 33 months; a quarter within 22 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartActual
Oct 20, 2026
Primary completionEst.
Oct 31, 2028
CompletionEst.
Oct 31, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911800
Lead sponsor
MIBIO PTE. LTD.
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Oct 20, 2026
Primary completion
Oct 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Joe Wu
Contact
joewu@3s-mibio.com
+65 66796282

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Recombinant human thrombopoietin

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Thrombocytopenia →

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