Idiopathic Thrombocytopenic PurpuraPhase 3NCT05492409
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
A Phase 3 study testing GNR-069 in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 13 sites in Russia.
Trial summary
It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- GNR-069
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 13 sitesRussia
- Study dates
- 28 Mar 2022to 3 Apr 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy
Who cannot join
- Hypersensitivity to the components of the study drug or E. Coli proteins;
- Pregnancy or breastfeeding;
- Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, 664079
State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
Kaluga, Kaluga Oblast, 248007
State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov" Department of Health of the city of Moscow
Moscow, 111123
Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
Moscow, 125167
State budgetary health care institution of the city of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow"
Moscow, 127644
State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
Llc "Medis"
Nizhny Novgorod, Nizhny Novgorod Oblast, 603137
Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
Novosibirsk, Novosibirsk Oblast, 630091
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don, Rostov Oblast, 344022
Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Saint Petersburg, 191014
State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
Tula, Tula Oblast, 300053
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Bashkortostan Republic, 450008
Municipal budgetary institution "Central City Hospital No. 7"
Yekaterinburg, 620137
About this study
Official title: Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial
It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura
Read the detailed description
It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.
The study will be conducted in three stages:
- Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);
- Treatment period - minimum 26 weeks;
- Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- GNR-069
- Keywords
- Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Hemorrhage, Purpura, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-069Biological
Also called romiplostim
Once a week as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| GNR-069 | Experimental | Weekly subcutaneous injections of GNR-069 in the individually titrated dose. Receives: Biological: GNR-069 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events associated with the use of the GNR-069
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Measured: up to 29 weeks
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Measured: up to 29 weeks
Number of clinically significant bleeding on Visits 1-5
The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Measured: up to 29 weeks
Number and proportion of the patient with antidrug antibodies.
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
Measured: up to 29 weeks
Secondary outcomes (3)
Frequency of the loss of the treatment response
Loss of the treatment response is assessed as absense of platelet increase ≥ 50,0 х 109/L on the 4 weeks treatment with maximal study drug dose.
Measured: up to 27 weeks
Platelet count dynamics at Visits 1-5
The platalets must be counted till week 5
Measured: up to 5 weeks
Сhange in ITP-BAT bleeding scores from baseline to week 27
ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27.
Measured: up to 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start28 Mar 2022
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A. Markova, MD, MSc, Study chair, AO GENERIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492409
- Sponsor's protocol ID
- RMP-ITP-III-X
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial
- ClinicalTrials.gov ID
- NCT05492409
- Acronym / sponsor ID
- RMP-ITP-III-X
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura
Detailed description
It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.
The study will be conducted in three stages:
- Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);
- Treatment period - minimum 26 weeks;
- Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GNR-069 | Experimental | Biological: GNR-069Weekly subcutaneous injections of GNR-069 in the individually titrated dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy
Key exclusion criteria (3 listed)
- Hypersensitivity to the components of the study drug or E. Coli proteins;
- Pregnancy or breastfeeding;
- Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNR-069Also: romiplostimOnce a week as a subcutaneous injection. | Biological | GNR-069 |
Primary outcome
Frequency and severity of adverse events associated with the use of the GNR-069
Time frame: up to 29 weeks
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
Time frame: up to 29 weeks
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Number of clinically significant bleeding on Visits 1-5
Time frame: up to 29 weeks
The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Number and proportion of the patient with antidrug antibodies.
Time frame: up to 29 weeks
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
3 secondary outcomes
Frequency of the loss of the treatment response
Time frame: up to 27 weeks
Platelet count dynamics at Visits 1-5
Time frame: up to 5 weeks
Сhange in ITP-BAT bleeding scores from baseline to week 27
Time frame: up to 27 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana A. Markova, MD, MSc study chair
AO GENERIUM
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GNR-069 in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 13 sites in Russia.
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 1 inclusion and 3 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. 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 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?
Frequency and severity of adverse events associated with the use of the GNR-069 (time frame: up to 29 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.