Trial · NCT07347990
Safety and Efficacy of Iptacopan in Patients With High-Risk Transplantation-Associated Thrombotic Microangiopathy
NCT07347990, Not applicable, Recruiting, First Affiliated Hospital of Zhejiang University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Iptacopan in Patients With High-Risk Transplantation-Associated Thrombotic Microangiopathy. Trials, record NCT07347990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07347990
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Iptacopan in Patients With High-Risk Transplantation-Associated Thrombotic Microangiopathy
- NCT number
- NCT07347990
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 30 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Conditions
- Thrombotic Microangiopathy, Hematopoietic Stem Cell Transplantation (HSCT)
- Interventions
- iptacopan
- First posted
- 2026-01-16
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Six-month Overall Survival Rate Following TA-TMA Diagnosis | From the date of TA-TMA diagnosis until 6 months post-diagnosis. | The primary endpoint is defined as the proportion of patients who remain alive at 6 months after the initial diagnosis of transplantation-associated thrombotic microangiopathy (TA-TMA). Survival status will be systematically assessed through follow-up visits, medical record review, or direct patient contact at the 6-month timepoint. |
| Secondary | TA-TMA Complete Response Rate by Week 12 (Jodele Criteria) | 12 weeks from start of treatment. | Proportion of patients achieving complete response of TA-TMA according to Jodele criteria within 12 weeks of treatment initiation. |
| Secondary | TA-TMA Partial Response Rate by Week 12 (Jodele Criteria) | 12 weeks from start of treatment. | Proportion of patients achieving partial response of TA-TMA (defined as response between complete response and no response) within 12 weeks of treatment initiation. |
| Secondary | Overall Survival (OS) | Up to 24 months from diagnosis. | Time from TA-TMA diagnosis to death from any cause. |
| Secondary | Non-Relapse Mortality (NRM) | Up to 24 months from diagnosis. | Time from TA-TMA diagnosis to death not attributable to hematologic disease relapse or progression. |
| Secondary | Cumulative Incidence of Relapse (CIR) | Up to 24 months from diagnosis. | Time from TA-TMA diagnosis to hematologic disease relapse or progression. |
| Secondary | Mean Hemoglobin Change from Baseline | Baseline to 12 weeks. | Change in mean hemoglobin level (g/dL) from baseline to specified time points |
| Secondary | Exploratory Biomarker Analysis | Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks after treatment . | Exploratory analysis of complement pathway biomarkers including C5b-9 (ng/mL) and Factor B (ng/mL) levels . |
| Secondary | Failure-Free Survival (FFS) | Up to 12 weeks from treatment initiation. | Time (in days) from treatment initiation to first occurrence of TA-TMA response among responders. |
| Secondary | Incidence of Acute and Chronic GVHD | Up to 24 months from treatment initiation. | Incidence of acute and chronic graft-versus-host disease. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Papers10
The papers the trial lists on ClinicalTrials.gov.
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/NCT07347990
GET https://conductscience.org/api/trials/v1/NCT07347990/registered