Trial · NCT04655092
Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
NCT04655092, Phase 3, Recruiting, PharmaEssentia Japan K.K.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients. Trials, record NCT04655092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04655092
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
- NCT number
- NCT04655092
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 67 participants, estimated
- Lead sponsor
- PharmaEssentia Japan K.K.
- Conditions
- Polycythemia Vera (PV)
- Interventions
- P1101 (Ropeginterferon alfa-2b)
- First posted
- 2020-12-07
- Last updated
- 2024-11-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks | Through study completion, an average of 2 year | CHR will be defined as follows. * Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks) * Platelet count ≤ 400 x 10\^9/L * WBC count ≤ 10 x 10\^9/L |
| Secondary | Changes in hematocrit every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Changes in white blood cell every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Changes in platelet count every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Changes in red blood cell count every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Changes in spleen size every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Necessity of phlebotomy | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Proportion of subjects without thrombotic or hemorrhagic events | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Secondary | Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time | Through study completion, an average of 2 year | Baseline is defined as Week 52 in Study A19-201 |
| Other | Bone marrow histological remission (optional) | Through study completion, an average of 2 year | Bone marrow histological remission was defined as the disappearance of hypercellularity and trilineage growth (panmyelosis), and absence of \>grade 1 reticulin fibrosis in the subjects who gave informed consent in Study A19-201 |
Source ClinicalTrials.gov
Outcomes0
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/NCT04655092
GET https://conductscience.org/api/trials/v1/NCT04655092/registered