A Phase 1/2 interventional study of Baricitinib in Persistent Thrombocytopenia and Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Peking University People's Hospital · Phase 1/2, Interventional, and Treatment
Among 108 studies in Thrombocytopenia with a site in China — 42 open to participants now, 45 under way, 10 of them phase 3. Thrombocytopenia · China.
Among the 108 studies in Thrombocytopenia with a site in China, this one is the 82nd largest by planned enrollment of the 96 interventional ones that give a count, is one of 6 that started in 2026, is one of 4 in phase 1/2, reaches primary completion later than 36 of the 44 other live ones, and was the 100th registered.
482 studies on the registry are indexed under Thrombocytopenia; 100 are open to participants now.
Browse Thrombocytopenia studies →42 of the 108 studies in Thrombocytopenia with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Jiangsu HengRui Medicine Co., Ltd. · Sites in China, United States, Bulgaria and 8 more countries
Zhejiang Cancer Hospital · Sites in China
Peking University People's Hospital · Sites in China
Peking University People's Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 66 Thrombocytopenia studies recruiting now, 44 (67%) set no upper age limit and 18 (27%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
108 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 47 · Phase 3 32 · Phase 4 11
First in 2006; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 28 is below the median of 54 across 334 interventional studies indexed under Thrombocytopenia.
Median enrollment 82 across the 96 interventional studies, 114 across the 12 observational. Of the 41 that completed or were terminated, 9 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 108 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Peking University People's Hospital has 7 studies filed under Thrombocytopenia — fewer than ten, so there is no comparison to draw.
6 of the studies in Thrombocytopenia with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06456528Phase 3Qilu Pharmaceutical Co., Ltd.QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia | 2027-04-30 |
| NCT07442513Phase 3First Affiliated Hospital of Zhejiang UniversityComparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT | 2027-10-31 |
| NCT06898983Anhui Provincial HospitalEfficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia | 2027-01-31 |
| NCT07441720Zhejiang Cancer HospitalSafety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) | 2027-06-30 |
| NCT07586813Peking University People's HospitalRomiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors | 2027-10-31 |
Among the 108 studies in Thrombocytopenia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, open-label phase 1b/2 clinical trial to explore the safety and efficacy profiles of baricitinib in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation.
Phase 1 part:
The phase 1b part will use a standard 3+3 design to explore the safety profiles and to establish the recommended phase 2 dose (RP2D) of baricitinib. The initial dose is 2 mg once daily, and the maximum dose is 4 mg once daily. Additional patients may be enrolled to further explore a selected dose defined by dose escalation cohorts (up to 9 patients in each dose level).
Phase 2 part:
The phase 2 part is a single-arm, open-label study to assess the efficacy and safety of baricitinib at RP2D in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation. Patients in phase 1b who were treated with baricitinib at the RP2D will be included in the phase 2 efficacy endpoint analyses.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A: Open label baricitinib at 2 mg daily (Phase 1) Group B: Open label baricitinib at 4 mg daily (Phase 1) Group C: Open label baricitinib at the RP2D (Phase 2)
Drug: Baricitinib
Baricitinib, an orally administered, selective, reversible JAK1/2 inhibitor.
Adverse events in the Ib part
The incidence and severity of adverse events are assessed using the criteria of CTCAE 5.0.
Time frame: 24 weeks
Overall response rate (ORR) for the IIa part
The proportion of patients achieving an overall response (OR), defined as a platelet count ≥20×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.
Time frame: 12 weeks
Overall response rate (ORR) for the Ib part
The proportion of patients achieving an overall response (OR), defined as a platelet count ≥20×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.
Time frame: 12 weeks
Complete response (CR)
The proportion of patients achieving a complete response (CR), defined as a platelet count ≥50×10\^9/L maintained for more than 7 days without transfusion support. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.
Time frame: 12 weeks
Durable response
The proportion of patients achieving a durable response (DR), defined as a platelet count ≥20×10\^9/L maintained for more than 8 weeks without transfusion. Platelet counts obtained within 4 weeks after rescue therapy were not included in the efficacy assessment.
Time frame: 24 weeks
Time to response
The time from the date of the first dose of baricitinib to the date of OR or CR.
Time frame: 12 weeks
Bleeding events
Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale: 0, no bleeding; 1, petechiae; 2, mild blood loss; 3, gross blood loss; and 4, debilitating blood loss.
Time frame: 24 weeks
Rescue medication
Time and type of rescue medications, defined as any additional treatment intended to prevent bleeding or raise the platelet counts, including a dose increase of more than 10% above baseline of the concomitant medication and any additional PT-modifying agents (e.g., corticosteroids, intravenous immunoglobulin, and platelet transfusions).
Time frame: 24 weeks
Adverse events in the IIa part
Adverse events (AEs) are reported and graded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: 24 weeks
Overall Survival (OS)
The overall survival of patients who received at least one dose of baricitinib in the study.
Time frame: 104 weeks
Transplantation-related mortality (TRM)
All deaths without relapse or disease progression occurring after transplantation as a direct or indirect consequence of the transplant procedure or associated complications in patients who received at least one dose of baricitinib in the study.
Time frame: 104 weeks
Relapse or progression of underlying disease
Relapse or progression of underlying disease of patients who received at least one dose of baricitinib in the study.
Time frame: 104 weeks
Graft-versus-host disease
The incidence and severity of acute graft-versus-host disease and chronic graft-versus-host disease in patients who received at least one dose of baricitinib in the study.
Time frame: 104 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Baricitinib
Peking University People's Hospital →