New hope for bleeding risk in hepatitis b patients?
NCT ID NCT03664518
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug eltrombopag in 48 Chinese adults with chronic hepatitis B and a bleeding disorder called immune thrombocytopenia (low platelets). The goal was to see if taking eltrombopag for 6 to 22 weeks could safely raise platelet counts. The trial is complete, but results are not yet published.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eltrombopag
- What this could lead to
- If successful, this could offer a treatment option for low platelet counts in people with chronic hepatitis B, reducing bleeding risk.
- What could go wrong
- This is a small, single-arm phase 2 trial with no placebo group, so results are preliminary. Eltrombopag may cause liver issues or blood clots, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Dec 2018
- Finished
-
Sep 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed written informed consent. * Subject is ≥18 years old. * Diagnosis of HBV-infection duration for at least 6 months prior to the study and have a platelet count of \<30 ×109/L on Day 1 (or within 48 hours prior to dosing on Day 1). * Complete blood count results: white blood cells, absolute neutrophils count and hemoglobin are within the laboratory normal range, but abnormalities caused by HBV infection can be accepted. * Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study. Exclusion Criteria: * Liver cirrhosis (LC) defined as any of the following: 1. Any symptom or sign typical of hepatic decompensation: including but not limited to ascites, splenomegaly, dilation of periumbilical collateral veins, hepatic encephalopathy 2. Child-Pugh class B to C Biopsies are not required either for confirmation or for exclusion of LC, considering the high bleeding risk in these patients. * Positive serology for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV). * Pregnancy or lactation period. * History of alcohol/drug abuse or dependence within 12 months of the study. * History of thrombosis. * The serum chemistry results exceed the upper laboratory normal range by more than 20%; except AST, ALT, GGT, ALP of CTCAE grade 1. * Bone marrow examination conducted within 4 weeks prior to first dose reported an abnormal result, which in the opinion of the investigator makes the subject unsuitable for participation in the study. * Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block. * Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for \>3 consecutive days within 2 weeks prior to the study start and until the end of the study. * Non-compliant patient * Reluctance to take effective contraceptive measures during the trial * History of solid organ or bone marrow transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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