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Primary Immune ThrombocytopeniaPhase 3NCT05621330

Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

A Phase 3 study testing QL0911 in people with Primary Immune Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. at 1 site 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

QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Immune Thrombocytopenia
What is being tested?
QL0911
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
1 siteChina
Study dates
18 Oct 2019to 16 Dec 2021
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years old;
  • Diagnosed primary ITP for at least 12 months;
  • Had received at least one first-line ITP treatment with no response or recurrence after treatment;
  • Had a platelet count <30×10^9/L within 48 hours before the first dose;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
  • Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.

Who cannot join

  • Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.
  • Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.
  • Underwent splenectomy within 12 weeks before the first dose;
  • Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;
  • Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;
  • Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator;
  • Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >3 ULN, hemoglobin < 100g/L, absolute neutrophil count <1.5x10^9/L;
  • Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital of Shandong University

    Shandong

Other trials in China

About this study

Official title: Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Trial

QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.

Read the detailed description

This study consisted of a randomized, double-blind, placebo-controlled, 26-week treatment period, sequentially followed by an open-label, single-arm, 12-week treatment period, and an additional 4-week safety follow-up period.

Being tested
QL0911, Placebo comparator
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.

  • QL0911Drug

    The study in a 2:1 randomization ratio(144 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

  • Placebo comparatorDrug

    The study in a 2:1 randomization ratio(72 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Study groups in NCT05621330
Study groupRoleWhat they receive
QL0911ExperimentalNot described
Receives: Drug: QL0911
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo comparator

What is being measured

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

  1. proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period

    Measured: 24weeks

Secondary outcomes (2)

  1. proportion of patients with weekly platelet responses within 24 weeks of treatment;

    Measured: 24weeks

  2. Proportion of patients who achieved platelet count ≥ 30 × 10^9/L at least a two-fold increase from baseline platelet count without bleeding during the 24-week double-blind period;

    Measured: 24weeks

Timeline

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

  1. First posted18 Nov 2022
  2. Study start18 Oct 2019
  3. Primary completion13 Dec 2021
  4. Study completion16 Dec 2021

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621330
Sponsor's protocol ID
QL0911-003
Status last verified
Nov 2022
First submitted
10 Nov 2022
Last updated
23 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou H, Han S, Jin J, Huang R, Guo X, Shen X, Wang B, Wang X, Yao H, Du X, Huang M, Ran X, Wang W, Yang T, Zhang F, Zheng C, Zuo X, Fu R, Gao D, Ge Z, Han Y, Li Y, Kang X, Shi Y, Hou M. Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. J Transl Int Med. 2023 Dec 20;11(4):423-432. doi: 10.2478/jtim-2023-0106. eCollection 2023 Dec.

    PubMed 38130645

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QL0911 in people with Primary Immune Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. at 1 site 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 6 inclusion and 8 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 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

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?

proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period (time frame: 24weeks). 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 NCT05621330, 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 23 Nov 2022.

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