Trial · NCT05870475
Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
NCT05870475, Phase 2, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV. Trials, record NCT05870475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05870475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
- NCT number
- NCT05870475
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 94 participants, estimated
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Conditions
- Polycythemia Vera
- Interventions
- Ruxolitinib, Pegylated interferon α-2b
- First posted
- 2023-05-23
- Last updated
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The cumulative complete hematologic response (CHR) rate | From the start of study treatment (Week 0) up to the end of Week 24. | The proportion of patients who can achieve CHR ( defined as hematocrit lower than 45% without phlebotomies; platelet count \< 400×109/L, WBC count \< 10×109/L for at least 12 weeks) among all patients. |
| Secondary | Cumulative CHR rates at Week 36. | From the start of study treatment (Week 0) up to the end of Week 36. | Cumulative CHR rates at Week 36 will be compared between the two groups. |
| Secondary | Cumulative CHR rates at Week 52. | From the start of study treatment (Week 0) up to the end of Week 52. | Cumulative CHR rates at Week 52 will be compared between the two groups. |
| Secondary | Time to CHR | From the start of study treatment (Week 0) up to the end of Week 52. | The time of reaching CHR will be compared between the two groups. |
| Secondary | The CHR rates after crossover | From the start of study treatment (Week 0) up to the end of Week 52. | The CHR rates within 52 weeks after crossover |
| Secondary | The rate of reduction in JAK2V617F, CALR, or MPL gene mutation burden. | From the start of study treatment (Week 0) up to the end of Week 52. | The rate of reduction in JAK2V617F, CALR, or MPL gene mutation burden will be compared between the two groups. |
| Secondary | Impact of therapy on non-driver mutations | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the proportion of subjects that display change on key non-driver biomarkers of the disease-DNMT3A, ASXL1, TET2 or other mutations. |
| Secondary | Change of splenomegaly | From the start of study treatment (Week 0) up to the end of Week 52.] | All subjects with palpable splenomegaly at baseline will undergo ultrasound examination. For subjects with palpable splenomegaly at baseline: Improvement - no palpable splenomegaly during clinical treatment visits; No progress - ultrasound examination during clinical treatment visits shows an increase in spleen size of ≤ 25%; Progress - Ultrasound examination during clinical treatment visits shows an increase in spleen size of\>25%. |
| Secondary | Change of bone marrow pathology | From the start of study treatment (Week 0) up to the end of Week 52 | Bone marrow histological remission defined as the presence of age-adjusted normocellularity and disappearance of trilinear hyperplasia, and absence of grade 1 reticulin fibrosis; no remission defined as the persistence of trilinear hyperplasia; progression defined as disease transformation into post-PV myelofibrosis, myelodysplastic syndrome or acute leukemia. |
| Secondary | The incidence of major thrombotic events | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the incidence of major thrombotic events between the two groups. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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/NCT05870475
GET https://conductscience.org/api/trials/v1/NCT05870475/registered