Trial · NCT07347990
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Multiple Organ Dysfunction Syndrome (MODS) Involvement and Resolution | Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after treatment; thereafter, every three months until study completion | Assessment of MODS organ involvement and resolution status during treatment. |
| Secondary | Safety and Tolerability Assessment | From treatment initiation to 30 days after last dose. | Frequency, duration, and severity of adverse events monitored through physical examinations and laboratory assessments, including infections and secondary primary malignancies. Adverse events will be graded according to CTCAE v4.03. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07347990/registered