Health TrialsbyHealthPanel

Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

ConditionImmune Thrombocytopenia (ITP)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ITP confirmed by excluding other supervened causes of thrombocytopenia;

Platelet count of less than 30×10^9/L at enrollment;

Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;

Disqualifiers

Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);

Congestive heart failure;

Severe arrhythmia;

Nursing or pregnant women;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iguratimod

    Drug

    oral iguratimod at 25mg twice daily for 26 weeks

  • low-dose rituximab

    Drug

    rituximab 100mg once weekly for 6 weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Iguratimod plus low-dose rituximabExperimental treatment 2 interventions
Group B: Low-dose rituximabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

overall response

The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.

Time frame
From the start of study treatment (Day 1) up to the end of Year 1

Secondary outcomes

1

sustained response

The number of participants that can maintain the platelet count \> 30 x 109/L, an absence of bleeding events, and without requirement for any other ITP-specific treatment for 6 consecutive months after achievement of response.

Time frame
From the start of study treatment (Day 1) up to the end of Year 1
2

complete response

The number of participants (responders) with platelet count\>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.

Time frame
From the start of study treatment (Day 1) up to the end of Year 1
3

time to response

Time to response was defined as the time from starting treatment to the time to achieve the response.

Time frame
From the start of study treatment (Day 1) up to the end of Year 1
4

duration of response

Duration of response was measured from the achievement of response to the loss of response.

Time frame
From the start of study treatment (Day 1) up to the end of Year 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Beijing Hospital

Collaborator

Beijing Friendship Hospital

Collaborator

Navy General Hospital, Beijing

Collaborator

Beijing Tongren Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: