Trial · NCT07057778
Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
NCT07057778, Phase 2, Not yet recruiting, Peking University People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP. Trials, record NCT07057778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07057778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
- NCT number
- NCT07057778
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Peking University People's Hospital
- Conditions
- Immune Thrombocytopenia (ITP)
- Interventions
- Iguratimod, low-dose rituximab
- First posted
- 2025-07-10
- Last updated
- 2025-07-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | overall response | From the start of study treatment (Day 1) up to the end of Year 1 | 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. |
| Secondary | sustained response | From the start of study treatment (Day 1) up to the end of Year 1 | 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. |
| Secondary | complete response | From the start of study treatment (Day 1) up to the end of Year 1 | 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. |
| Secondary | time to response | From the start of study treatment (Day 1) up to the end of Year 1 | Time to response was defined as the time from starting treatment to the time to achieve the response. |
| Secondary | duration of response | From the start of study treatment (Day 1) up to the end of Year 1 | Duration of response was measured from the achievement of response to the loss of response. |
| Secondary | incidence of adverse events | All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0 | From the start of study treatment (Day 1) up to the end of Year 1 |
| Secondary | Bleeding events | From the start of study treatment (Day 1) up to the end of Year 1 | Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale. |
| Secondary | Health-related quality of life (HRQoL) | From the start of study treatment (Day 1) up to the end of Year 1 | ITP-PAQ is used to assess the Health Related Quality of Life (HRQoL) before and after treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07057778
GET https://conductscience.org/api/trials/v1/NCT07057778/registered