Trial · NCT03939637
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With a Platelet Response | 12 weeks | To determine if the percentage of patients with a platelet response is significantly greater in patients with newly diagnosed ITP treated with eltrombopag than those treated with standard first-line treatments |
| Secondary | Bleeding Score | 1 year | Poor bleeding score (binary) at 1, 2, 3, 4 weeks, 12 weeks, and 1 year after study enrollment defined as World Health Organization (WHO) Bleeding Scale ≥ 2 or Modified Buchanan Scale ≥ 3 |
| Secondary | Cumulative Number of Rescue Therapies Required | 12 weeks | The percentage of patients who received rescue therapy in the experimental (eltrombopag) arm vs the comparator (standard therapy) arm during the first 12 weeks of treatment |
| Secondary | Platelet Response Among Patients Requiring Rescue Therapy During Weeks 1-2 of Study | 12 weeks | Platelet response (binary), defined as ≥ 3 of 4 weeks with platelets \>50 x109/L during weeks 6-12 of therapy, but patient required a rescue treatment during weeks 1-2 of study. |
| Secondary | Need for Treatment | 6 months | No further need for treatment (binary) after 12 weeks or 6 months of study |
| Secondary | Treatment Response | 1 year | Treatment response (binary endpoints) at 1 year defined as: * CR is defined as platelet count \>/= 150 x 10\^9/L * Primary Remission at 1 year is defined as CR at 1 year with no second-line agents required and \>/= 3 months after discontinuing most recent platelet active medication * Disease resolution at 1 year is defined as complete response (CR) at 1 year \>/= 3 months after discontinuing most recent platelet active medication. May have received a second-line therapy, excluding rituximab or splenectomy. * Disease stability at 1 year is defined as platelets \>/= 50 x 10\^9/L but \<150 x 10\^9/L \>/= 3 months after discontinuing most recent platelet active medication. |
| Secondary | Number of 2nd Line Therapies | 52 weeks | Number of 2nd-line therapies in weeks 13-52 |
| Secondary | Regulatory T-Cells | 1 year | Absolute change in percentage of CD4+25+Foxp3+ regulatory T cells from baseline at 12 weeks and 1 year |
| Secondary | KIT Scores | 1 year | Change in parent proxy-reported Kids ITP tool (KIT) overall scores from baseline at 1 week, 4 weeks, 12 weeks, and 1 year after study enrollment |
| Secondary | Hockenberry Fatigue Scale-Parent | 1 year | Total scale intensity ratings (continuous) from the Hockenberry Fatigue Scale-Parent (FS-P) at 1 week, 4 weeks, 12 weeks, and 1 year |
| Secondary | Blood Iron Values | 1 year | Serum iron, total iron binding capacity (TIBC), transferrin saturation, ferritin, mean corpuscular volume (MCV), and hemoglobin at 12 weeks, 6 months, and 1 year after study enrollment |
| Secondary | Safety Evaluations | 1 year | Safety evaluations as defined by: * Abnormal liver function tests (LFTs): ALT ≥ 3 x upper limit of normal (ULN) in patients with normal baseline ALT ≥ 3 x baseline or ≥ 5 x ULN (whichever is lower) in patients with abnormal baseline ALT ≥ 3 x ULN AND bilirubin ≥ 1.5 x ULN (\>35% direct) * Incidence of adverse events * Incidence of serious adverse events |
| Other | Time to Response | 1 year | Time to response (platelets \>30x10\^9/L, and at least 2-fold increase in the baseline count and absence of bleeding) (IWG definition) |
| Other | Platelet-specific Endpoints | 1 year | Treatment response (platelets \>30x10\^9/L, and at least 2-fold increase in the baseline count and absence of bleeding) (IWG definition) at 12 weeks |
| Other | Time to Platelet Count | 1 year | Time to platelet count \>100x10\^9/L and absence of bleeding (IWG definition) |
| Other | Treatment Response | 1 year | Treatment response (platelet count \>100x10\^9/L and absence of bleeding) (IWG definition) at 12 weeks |
| Other | Loss of Treatment Response | 1 year | Loss of treatment response (platelet count below 30x10\^9/L, or less than 2-fold increase in the baseline count or bleeding) (IWG definition) at any time during the study period after achieving response during the first 12 weeks |
| Other | Extreme Thrombocytosis | 1 year | Extreme thrombocytosis (platelets \>1 x10\^12/L) |
| Other | Patient-reported Outcomes Endpoints | 1 year | Change in child self-reported and parent impact KIT scores from baseline at 1 week, 4 weeks, 12 weeks, and 1 year after study enrollment |
| Other | Change in Hockenberry Fatigue | 1 year | Change in Hockenberry fatigue (FS-C, FS-A, FS-P) scores from baseline at 1 week, 4 weeks, 12 weeks, and 1 year after study enrollment |
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/NCT03939637/registered