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Ropeginterferon for Treatment Free Remission

NCT07105319 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-22

No results posted yet for this study

Summary

Ropeginterferon is a long-acting next-generation mono-pegylated interferon alfa-2b consisting of one isoform produced by PharmaEssentia Co. and the pegylated (PEG) formulations that require less frequent administration and have improved efficacy and tolerability.

In this study, patients in the investigational arm will receive Ropeginterferon subcutaneously with 250 μg at week 0, 350 μg at week 2, 500 μg at week 4, and thereafter 500 μg bi-weekly until week 24.

Conditions

  • CML (Chronic Myelogenous Leukemia)

Interventions

DRUG

Ropeginterferon

1. Investigational arm with Ropeginterferon (50 patients): Patients will be treated with 250 μg at week 0, 350 μg at week 2, and then 500 μg at week 4, and thereafter bi-weekly subcutaneous injection until week 24 2. Comparator arm (50 patients): Patients will be followed with no further CML treatment

Sponsors & Collaborators

  • Dong-Wook Kim

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105319 on ClinicalTrials.gov