Trial · NCT05653219
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 | Time from randomization until treatment failure | Randomization to until end of study (up to 39 months after randomization of last participant) | Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: * platelet count below 30 G/L * start of a new ITP treatment * need for a rescue treatment * ineligibility to taper or inability to discontinue eltrombopag * death |
| Secondary | Stable response at 6 months (Key Secondary Endpoint) | At 6 months | Percentage of participants with at least 3 platelet count collected at month 6 (between study days 121 and 183 and at least 75% of platelet counts qualified as a response). |
| Secondary | Complete Response rate at each timepoint | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment |
| Secondary | Response rate at each timepoint | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment |
| Secondary | Best response rate across all timepoints | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with a best response rate of either response or complete response |
| Secondary | Time to first response/time to first complete response | Time from randomization up to the longest observed treatment period duration | Time from randomization to date of first response and time from randomization to date of first complete response |
| Secondary | Duration of response | Randomization to until end of study (up to 39 months after randomization of last participant) | Time from achievement of response to treatment failure. |
| Secondary | Stable response at 1 year | At 1 year | Percentage of participants with at least 2 platelet count collected at year 1 (between study days 296 and 379 and at least 66% of platelet counts qualified as a response). |
| Secondary | Duration of complete response | Randomization to end of study (up to 39 months after randomization of last participant) | Time from achievement of complete response to loss of complete response stable response at 1 year period |
| Secondary | Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm | up to week 24 | Probability to be treatment failure-free (as defined for the primary efficacy endpoint) |
| Secondary | Percentage of participants with bleeding events according to World Health Organization (WHO) | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants reporting bleeding events according to WHO bleeding scale |
| Secondary | Number of participants receiving rescue treatment | Randomization to until end of study (up to 39 months after randomization of last participant) | Number of participants who are in need of rescue treatment in each treatment arm |
| Secondary | Percentage of participants receiving rescue treatment | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants who are in need of rescue treatment |
| Secondary | Change from baseline in the frequency of CD19+ B-cell counts | Randomization to until end of study (up to 39 months after randomization of last participant) | Post-baseline frequency of CD19+ B-cell counts (percentage within CD45) compared to baseline |
| Secondary | Change from baseline in the absolute number of CD19+ B-cell counts | Randomization to until end of study (up to 39 months after randomization of last participant) | Post-baseline absolute number of CD19+ B-cell counts compared to baseline |
| Secondary | Change from baseline on T-score of the PROMIS SF v1.0 Fatigue 13a | From screening (baseline) until end of study (up 39 months after randomization of last participant) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults. |
| Secondary | Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity | From screening (baseline) until end of study (up 39 months after randomization of last participant) | 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, overall QoL. Each item is rated on a Likert type scale. Each scale is scored from 0 to 100. Higher scores represent better HRQoL. |
| Secondary | Time to first occurence of B-cell recovery defined as ≥80% of baseline ≥50 cells/µL | Randomization to until end of study (up to 39 months after randomization of last participant) | Time to B-cell recovery defined as ≥80% of baseline or ≥50 cells/µL |
| Secondary | Change from baseline in immunoglobulins | Randomization to until end of study (up to 39 months after randomization of last participant) | Change from baseline in immunoglobulin levels |
| Secondary | PK parameters: AUClast | After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose) | AUClast: Area under the curve from time zero to 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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GET https://conductscience.org/api/trials/v1/NCT05653219/registered