Trial · NCT05653349
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Stable Response off treatment at 12 months (SROT-12) | 12 months after last patient completed treatment | A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment). |
| Secondary | Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint) | Randomization to end of study (up to 39 months after randomization of last patient | Time to Treatment Failure (TTF) is defined as the time from randomization until the first of the following events/situation indicative of treatment failure: platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, intake of rescue treatment (e.g., corticosteroids, Intravenous immunoglobulins (IVIG), or platelet transfusion) given later than 8 weeks from randomization, start of new Immune Thrombocytopenia (ITP) treatment whenever it occurs, death (whatever the cause). |
| Secondary | Complete Response (CR) rate in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Complete Response (CR) rate at each timepoint defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment. |
| Secondary | Response (R) rate in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Response (R) rate at each timepoint defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment. |
| Secondary | Time to complete response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Time from randomization to date of first complete response. |
| Secondary | Duration of response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Time from achievement of complete response to loss of complete response |
| Secondary | Stable response at 6 months | At 6 months | Percentage of participants with at least 2 platelet count collected at month 6 (between study dates 107 and 183) and at least 66% of platelet counts qualified as a response |
| Secondary | Stable response at 1 year | At 1 year | Percentage of participants with at least 2 platelet counts collected at year 1 (between study days 296 and 379) and at least 66% of platelet counts qualified as a response |
| Secondary | Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the incidence and severity of bleeding in each treatment arm |
| Secondary | Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the number and severity of bleeding in each treatment arm |
| Secondary | Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure) | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the number of participants receiving rescue treatment. |
| Secondary | Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure) | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the need of rescue treatment in each treatment group by percentage. |
| Secondary | Cumulative dose/duration of steroids exposure | From screening to end of study (up to 39 months after randomization of last patient) | Duration of exposure to corticosteroids calculated from randomization (first dose) to end of study or last last contact date (if the participant is lost to follow-up). |
| Secondary | Change from baseline on T scores of the PROMIS SF v1.0 Fatigue 13a | From screening (baseline) till end of study (up to 39 months after randomization of last patient) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue |
| Secondary | Change from baseline in ITP-PAQ domain scores | From screening (baseline) till end of study (up to 39 months after randomization of last patient) | The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women's Reproductive Health, and Overall QoL. Each item is rated on a Likert type scale |
| Secondary | Change from baseline in frequency of CD19+ B cell counts | Randomization to end of study (up to 39 months after randomization of last patient) | Post baseline frequency (%within the CD45) of CD19+ B cell counts compare to baseline. |
| Secondary | Change from baseline in absolute number of CD19+ B cell counts | Randomization to end of study (up to 39 months after randomization of last patient) | Post baseline absolute number of CD19+ B cell counts compare with baseline |
| Secondary | Time to first occurrence of B-cell recovery | Randomization to end of study (up to 39 months after randomized of last patient) | B-cell recovery is defined as ≥80% of baseline and ≥LLOQ, or ≥50 cells/μL |
| Secondary | Change from baseline in inmmunoglobulins | Randomization to end of study (up to 39 months after last randomized patients) | Change from baseline in immunoglobulin levels |
| Secondary | PK parameters: AUClast | After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose) | AUClast: area under the curve from time zero till the last measurable concentration sampling time (tlast) |
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
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