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A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms

NCT01387763 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-04-27

No results posted yet for this study

Summary

The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.

Conditions

Interventions

DRUG

PegIntron

PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.

DRUG

Pegasys

Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly

DRUG

PegIntron

PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.

DRUG

Pegasys

Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly

DRUG

Hydrea

Capsule Hydrea 500-2000 mg orally QD or BID

Sponsors & Collaborators

  • Thomas Stauffer Larsen

    lead OTHER

Principal Investigators

  • Thomas S Larsen, MD PhD · Dept. of Hematology, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT01387763 on ClinicalTrials.gov