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Previously Treated Primary Immune ThrombocytopeniaPhase 4TE-ITPNCT05583838

A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts

A Phase 4 study testing rhTPO and Eltrombopag in people with Previously Treated Primary Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
rhTPO and Eltrombopag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
17 sitesChina
Study dates
22 Nov 2022to 16 Jul 2024
Phase
Phase 4
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥18 years old.
  • Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
  • Baseline platelet count <30×10^9/L.
  • Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
  • Informed consent has been signed.

Who cannot join

  • Classified as refractory ITP.
  • Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
  • Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
  • Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
  • Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA >1000cps/ml.
  • TBil or Scr> 1.5 x upper limit of normal (ULN), ALT or AST> 3.0 x ULN in recently 2 weeks.
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  • Subjects with any prior history of tumor.
  • Female subjects who are nursing or pregnant.
  • Any situation that investigate consider not suitable for pts to join the study.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010107

  • Kashgar District 1st People's Hospital

    Kashgar, Xinjiang, 844000

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530007

  • the Second Hospital of HeBei Medical University

    Shijiazhuang, Hebei, 050000

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Heibei, 063000

  • Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

    Tianjin, Tianjin Municipality, 300020

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • The first affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Xi'an Central Hospital

    Xi'an, Shaanxi, 710032

  • Xijing Hospital of the Fourth Military Medical University

    Xi'an, Shaanxi, 710032

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • Yuyao People's Hospital of Zhejiang Province

    Yuyao, Zhejiang, 315400

  • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

Read the detailed description

A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".

Being tested
rhTPO, Eltrombopag
Keywords
rhTPO, Eltrombopag, Pre-treated, Primary Immune Thrombocytopenia
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhTPODrug

    Also called Recombinant human thrombopoietin, TPIAO

    initial therapy: rhTPO s.c, 300 or 600U/kg daily based on baseline platelet count; maintenance therapy: rhTPO s.c, 300 ~ 600U/kg every other day depends on platelet count.

  • EltrombopagDrug

    Also called Eltrombopag olamine

    initial therapy: Eltrombopag oral, 25 or 50mg daily based on baseline platelet count; maintenance therapy: Eltrombopag oral, 25 ~ 75mg daily or every other day depends on platelet count.

Study groups in NCT05583838
Study groupRoleWhat they receive
Optimized rhTPO treatmentExperimentalThe study in a 2:1 randomization ratio (117 subjects to rhTPO group).
Receives: Drug: rhTPO
Eltrombopag treatmentActive comparatorThe study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
Receives: Drug: Eltrombopag

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation

    Time from the start of treatment to the first time of achieving a platelet count ≥50x10^9/L without salvage therapy during the first 6 weeks.

    Measured: in 6 weeks treatment

Secondary outcomes (10)

  1. Early response

    Early response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 week.

    Measured: after 1 week treatment

  2. Initial response

    Initial response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 month.

    Measured: after 1 month treatment

  3. 6 weeks response

    6 weeks response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 weeks.

    Measured: after 6 weeks treatment

  4. 4 months response

    4 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months.

    Measured: after 4 months treatment

  5. Durable response

    Durable response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 months.

    Measured: after 6 months treatment

  6. Time to treatment failure

    Treatment failure is defined as:

    • a platelet count < 30 x 10^9/L for 4 consecutive weeks at the highest dose and schedule ; or,
    • a major bleeding event; or,
    • a change in therapy due to an intolerable side effect or bleeding symptoms (including a minor bleeding event).

    Measured: in 6 weeks treatment

  7. Incidence of adverse events

    treatment-related adverse events.

    Measured: from study start date to the end of follow-up, up to 6 months

  8. Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0

    Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0

    Measured: from study start date to the end of follow-up, up to 6 months

  9. Number of subjects who develop anti-rhTPO antibodies

    Number of subjects who develop anti-rhTPO antibodies

    Measured: from study start date to the end of follow-up, up to 6 months

  10. The duration time with platelet count ≥50x10^9/L

    Total duration of time a subject had platelet count ≥50x10^9/L during treatment

    Measured: in 6 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start22 Nov 2022
  3. Primary completion28 Feb 2024
  4. Study completion16 Jul 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583838
Sponsor's protocol ID
IIT2022037
Acronym
TE-ITP
Status last verified
Apr 2025
First submitted
12 Oct 2022
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.

Publications

  • Chen Y, Sun T, Gao D, Wang W, Zhou Z, Gao G, Wang Y, Zhou H, Song Y, Lai Y, Yan Z, Yan J, Bai J, Zhang L. Dose-optimised recombinant human thrombopoietin versus eltrombopag in patients with immune thrombocytopenia: a multicenter, randomised controlled trial (The TE-ITP Study). EClinicalMedicine. 2025 Aug 21;87:103459. doi: 10.1016/j.eclinm.2025.103459. eCollection 2025 Sep.

    PubMed 40896456

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rhTPO and Eltrombopag in people with Previously Treated Primary Immune Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 17 sites 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation (time frame: in 6 weeks treatment). 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 NCT05583838, 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 24 Apr 2025.

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