A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Three Dosing Schedules of Oral Rigosertib in MDS Patients

NCT02075034

Myelodysplastic Syndrome

WITHDRAWN PHASE1

Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

NCT02000154

Myelodysplastic Syndrome

COMPLETED PHASE1

Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

NCT02045654

Myelodysplastic Syndrome

UNKNOWN

A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)

NCT02779569

Myelodysplastic Syndromes (MDS)

UNKNOWN NA

Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine

NCT01928537

Myelodysplastic Syndromes Refractory Anemia With Excess Blasts Chronic Myelomonocytic Leukemia +1 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MDS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KRN321

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
* Serum EPO concentration ≤ 500 mIU/mL
* Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations

Exclusion Criteria

* Previous bone marrow or hematopoietic stem cell transplantation
* History of pure red cell aplasia
* Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
* Those who have increased risk of thrombosis during the study
* Uncontrolled diabetes mellitus
* Concurrent active infection or chronic inflammatory disease
* Other causes of anemia
* Previous or concurrent active malignancies other than MDS

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No