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Purpura, Thrombocytopenic, IdiopathicPhase 4NCT03258866

The Study of Different Dose Rituximab in the Treatment of ITP

A Phase 4 study testing Rituximab in people with Purpura, Thrombocytopenic, Idiopathic and Immune Thrombocytopenia, run by Shandong University 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

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP). Read more about this study

Who is it for?
Ages 10 to 70 years
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
1 Jan 2010to 31 Dec 2016
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 10 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Meet the diagnostic criteria for immune thrombocytopenia.
  • Male or female, between the ages of 10 ~ 70 years.
  • Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
  • To show a platelet count < 30×10^9/L, or with bleeding manifestations.
  • Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2

Who cannot join

  • Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  • Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  • Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  • Patients who are deemed unsuitable for the study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu hospital, Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Read the detailed description

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Being tested
Rituximab
Keywords
thrombocytopenia, Immune Thrombocytopenia, purpura
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Purpura

What participants receive

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

  • RituximabDrug

    Also called Mabthera

    given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)

  • RituximabDrug

    Also called Mabthera

    given with a single dose of 375mg/m2

Study groups in NCT03258866
Study groupRoleWhat they receive
group AExperimentalIn group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
Receives: Drug: Rituximab
group BExperimentalIn group B, Rituximab was given with a single dose of 375mg/m2
Receives: Drug: Rituximab

What is being measured

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

  1. Evaluation of platelet response(continuous response rate)

    Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

    Measured: up to 1 year per subject

Secondary outcomes (1)

  1. therapy associated adverse events

    The number and frequency of therapy associated adverse events

    Measured: up to 1 year per subject

Timeline

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

  1. First posted23 Aug 2017
  2. Study start1 Jan 2010
  3. Primary completion31 Dec 2015
  4. Study completion31 Dec 2016

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
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258866
Sponsor's protocol ID
RTX 4v1 in ITP
Status last verified
Aug 2017
First submitted
18 Aug 2017
Last updated
23 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Auger S, Duny Y, Rossi JF, Quittet P. Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta-analysis. Br J Haematol. 2012 Aug;158(3):386-98. doi: 10.1111/j.1365-2141.2012.09169.x. Epub 2012 May 22.

    PubMed 22612239

  • Zaja F, Volpetti S, Chiozzotto M, Puglisi S, Isola M, Buttignol S, Fanin R. Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia. Am J Hematol. 2012 Sep;87(9):886-9. doi: 10.1002/ajh.23272. Epub 2012 Jun 20.

    PubMed 22718483

  • Grace RF, Bennett CM, Ritchey AK, Jeng M, Thornburg CD, Lambert MP, Neier M, Recht M, Kumar M, Blanchette V, Klaassen RJ, Buchanan GR, Kurth MH, Nugent DJ, Thompson AA, Stine K, Kalish LA, Neufeld EJ. Response to steroids predicts response to rituximab in pediatric chronic immune thrombocytopenia. Pediatr Blood Cancer. 2012 Feb;58(2):221-5. doi: 10.1002/pbc.23130. Epub 2011 Jun 14.

    PubMed 21674758

  • Reboursiere E, Fouques H, Maigne G, Johnson H, Chantepie S, Gac AC, Reman O, Macro M, Benabed K, Troussard X, Damaj G, Cheze S. Rituximab salvage therapy in adults with immune thrombocytopenia: retrospective study on efficacy and safety profiles. Int J Hematol. 2016 Jul;104(1):85-91. doi: 10.1007/s12185-016-1992-4. Epub 2016 Apr 4.

    PubMed 27040278

  • Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.

    PubMed 20546023

  • Garcia-Suarez J, Prieto A, Reyes E, Manzano L, Merino JL, Alvarez-Mon M. The clinical outcome of autoimmune thrombocytopenic purpura patients is related to their T cell immunodeficiency. Br J Haematol. 1993 Jul;84(3):464-70. doi: 10.1111/j.1365-2141.1993.tb03102.x.

    PubMed 8217798

  • Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Ronnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013 Mar 14;121(11):1976-81. doi: 10.1182/blood-2012-09-455691. Epub 2013 Jan 4.

    PubMed 23293082

  • Brah S, Chiche L, Fanciullino R, Bornet C, Mancini J, Schleinitz N, Jean R, Kaplanski G, Harle JR, Durand JM. Efficacy of rituximab in immune thrombocytopenic purpura: a retrospective survey. Ann Hematol. 2012 Feb;91(2):279-85. doi: 10.1007/s00277-011-1283-3. Epub 2011 Jun 28.

    PubMed 21710166

  • Ni X, Li D, Yuan C, Yu Y, Wang H, Wang L, Yu T, Qin P, Peng J, Hou M, Shi Y, Hou Y. Single-dose versus low-dose rituximab in corticosteroid-resistant or relapsed ITP: A multicenter, randomized, controlled study. Am J Hematol. 2022 Apr;97(4):440-447. doi: 10.1002/ajh.26473. Epub 2022 Jan 25.

    PubMed 35049070

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab in people with Purpura, Thrombocytopenic, Idiopathic and Immune Thrombocytopenia, run by Shandong University 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 5 inclusion and 5 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 Aug 2017. 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. 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?

Evaluation of platelet response(continuous response rate) (time frame: up to 1 year per subject). 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 NCT03258866, which also lists 9 linked publications.

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 Aug 2017.

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