Trial · NCT06002490
A Study to Evaluate P1101 in Japanese PV Patients
NCT06002490, Phase 3, Completed, PharmaEssentia Japan K.K.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate P1101 in Japanese PV Patients. Trials, record NCT06002490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06002490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate P1101 in Japanese PV Patients
- NCT number
- NCT06002490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- PharmaEssentia Japan K.K.
- Conditions
- Polycythemia Vera (PV)
- Interventions
- P1101, Low-dose aspirin, Phlebotomy
- First posted
- 2023-08-21
- Last updated
- 2024-11-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Who Achieved Durable Phlebotomy-free Complete Hematological Response (CHR) at Week 24 | 24 weeks | |
| Secondary | Rate of achieving "phlebotomy-free complete hematologic response (CHR)" (the same criteria as for the primary efficacy endpoint) at both Week 12 and Week 24. | Week12, Week24 | |
| Secondary | Time to achieve CHR | Up to Week24 | |
| Secondary | Time to reach response maintenance dose (three consecutive doses of the same dose) | Up to Week24 | |
| Secondary | Numbers of phlebotomy required and changes in numbers of phlebotomy required from baseline | Baseline, up to Week24 | |
| Secondary | Time to first response in peripheral blood count (Hct, WBC, and PLT) | Up to Week24 | |
| Secondary | Duration of response in peripheral blood count (Hct, WBC, and PLT) | Up to Week24 | |
| Secondary | Improvement of symptoms assessed by MPN-SAF TSS at each visit | Up to Week24 | Rated on a scale of 0-10 on an 11-point scale, with 0 being no symptoms, 1 being the best, and 10 being the worst. |
| Secondary | Proportion of subjects without thrombotic or hemorrhagic events at Weeks 12 and 24 | Week12, week24 | |
| Secondary | Change from baseline to Week 24 in JAK2 V617F allele burden level | Baseline, week24 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT06002490
GET https://conductscience.org/api/trials/v1/NCT06002490/registered