Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera

Polycythemia Vera Clinical Trial

— PV  

Official title:

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera - A Randomized Open Label Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290765
• Other study ID #: A23-401
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: February 2024
• Source: PharmaEssentia
• Contact: Ting-Fang Wang
• Phone: +886-2-26557688
• Email: tingfang_wang[@]pharmaessentia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Patients =18 and ?60 years old;

2. PV according WHO 2022 Criteria;

3. Low-risk PV according to the NCCN guideline;

4. Hct value lower than 45%;

5. JAK2 V617F or exon 12 mutation AND a bone marrow biopsy performed with morphology consistent with PV and reticulin fibrosis grade of 0-1;

6. Females of childbearing potential must agree to use an acceptable form of birth control;

7. Written informed consent obtained from the patient or the patient's legal representative

Exclusion Criteria:

1. Previous well documented cardiovascular PV-related events;

2. Prior use of cytoreductive agents in the past 4 weeks prior to randomization;

3. Any contraindication to pegylated interferon or its excipients;

4. Non-responder or resistance to interferon or any other cytoreductive therapies;

5. Documented autoimmune disease at screening or in the medical history;

6. Prior or current autoimmune thyroid disease;

7. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol;

8. Infections with systemic manifestations except hepatitis B (HBV) and/or hepatitis C (HCV), at screening;

9. Any investigational drug less than 6 weeks prior to the first dose of study drug;

10. History or presence of depression requiring treatment with antidepressant;

11. Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator;

12. Any significant morbidity or abnormality which may interfere with the study participation;

13. Pregnant or lactating females;

14. History of alcohol abuse or drug abuse within the last year;

15. Evidence of severe retinopathy;

16. Significant liver or renal disease;

17. History of major organ transplantation;

18. History or presence of clinically significant neurologic diseases;

19. History of malignant disease, including solid tumours and hematological malignancies within the last 3 years.

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• Ropeginterferon alfa-2b
Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), 250 µg at Day 1, 350 µg at Week 2, and target optimal dose of 500 µg at Week 4.

Procedure:
• Phlebotomy
Control group patients will receive phlebotomy only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEssentia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with treatment response evaluated. Treatment response is defined as the maintenance of the median HCT values <45% over time, without progression of disease, and no need of any extra-protocol cytoreductive drugs.		from baseline to Week 56