Trial · NCT07597395
ATRA for Management of Primary ITP
NCT07597395, Phase 3, Not yet recruiting, Peking University People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ATRA for Management of Primary ITP. Trials, record NCT07597395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07597395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ATRA for Management of Primary ITP
- NCT number
- NCT07597395
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 192 participants, estimated
- Lead sponsor
- Peking University People's Hospital
- Conditions
- Immune Thrombocytopenia
- Interventions
- all-trans retinoic acid (ATRA), Placebo
- First posted
- 2026-05-19
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07597395
GET https://conductscience.org/api/trials/v1/NCT07597395/registered