Clinical trial · Interventional
Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)
NCT04655092CI-TRIAL-00082406recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera (PV) | Polycythemia Vera | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P1101 (Ropeginterferon alfa-2b) | Biological | Ropeginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- P1101 (Ropeginterferon alfa-2b)
- description
- Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.
- interventionNames
- Biological: P1101 (Ropeginterferon alfa-2b)
Primary outcomes (1)
- measure
- Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks
- timeFrame
- Through study completion, an average of 2 year
- description
- 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 outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study * Patients who have given written informed consent to participate in this study Exclusion Criteria: * Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
References
Publications (0)
Data not yet available
No reference posted for this study.