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

February 29, 2024 updated by: PharmaEssentia

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropeginterferon alfa-2b group
Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), target optimal dose of 500 µg. Phlebotomy should be conducted when Hct ≥ 45%.
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.
Other Names:
  • P1101
Other: Control group
Phlebotomy only and should be conducted when Hct ≥ 45%.
Procedure: Phlebotomy
Control group patients will receive phlebotomy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: from baseline to Week 56
from baseline to Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaEssentia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A23-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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