Trial · NCT07597395
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Durable platelet response | Up to week 24 | Platelet count of ⩾50 × 10\^9/L or between ⩾30 × 10\^9/L and \<50 × 10\^9/L and at least doubled from baseline on at least four of six scheduled visits between weeks 14 and 24 |
| Secondary | 24-week overall response rate | Up to week 24 | From enrollment to the end of week 24, the proportion of patients with at least one platelet count of ≥50×10⁹/L or between 30 × 10\^9/L and 50 × 10\^9/L plus at least doubled from baseline |
| Secondary | 12-week overall response rate | Up to week 12 | From enrollment to the end of week 12, the proportion of patients with at least one platelet count of ≥50×10⁹/L or between 30 × 10\^9/L and 50 × 10\^9/L plus at least doubled from baseline |
| Secondary | Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 30×10^9/L) | Up to week 24 | The proportion of participants who achieved platelet counts ≥ 30×10\^9/L and at least doubled from baseline at two consecutive visits |
| Secondary | Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 50×10^9/L) | Up to week 24 | The proportion of patients with two consecutive platelet counts of 50×10⁹/L or more and doubling from the baseline count |
| Secondary | Quality of Life Score | Up to week 24 | ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment. |
| Secondary | Adverse Events | Up to week 28 | The rate of participants with adverse events |
| Secondary | Complete response rate | Up to week 24 | The proportion of patients with a platelet count of ≥ 100×10\^9/L in absence of bleeding at any time |
| Secondary | Duration of response | Up to 24 weeks | Number of weeks with platelet count of ≥50 × 10\^9/L or between 30 × 10\^9/L and 50 × 10\^9/L plus at least doubled from baseline |
| Secondary | Time to response | Up to week 24 | Time from treatment initiation to first platelet count reaching ≥30x10\^9/L and doubling from the baseline count in 0-24 weeks |
| Secondary | Initial response | Up to week 4 | Platelet count ≥30×10\^9/L and at least doubling baseline at day 28 |
| Secondary | Peak platelet count | Up to week 24 | The peak platelet count without rescue treatment |
| Secondary | Bleeding events | 0-12 weeks and 0-24 weeks | Bleeding incidence and severity per WHO bleeding score in 0-12 weeks and 0-24 weeks |
| Secondary | Rescue treatment | Up to week 24 | Proportion of patients receiving predefined rescue treatment |
| Secondary | Reduced or discontinued concomitant therapy | Up to week 24 | Proportion of patients with reduced or discontinued baseline concomitant anti-ITP therapy |
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.
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GET https://conductscience.org/api/trials/v1/NCT07597395/registered