NCT01381809

Brief Summary

The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
5 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3.3 years

First QC Date

June 23, 2011

Last Update Submit

March 14, 2016

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic SyndromesMyeloproliferative DisordersBone Marrow diseaseAnemiaEpoetin AlfaEprexErypoErythropoiesis-stimulating agent

Outcome Measures

Primary Outcomes (1)

  • Erythroid response

    at week 24

Secondary Outcomes (10)

  • Maintenance of Erythroid response

    every 4 weeks from week 24 to week 48

  • Duration of response

    every 4 weeks after week 24

  • Time to first Red Blood Cell transfusion

    from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)

  • Transfusion-free intervals

    from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)

  • Number of Red Blood Cell units transfused

    from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)

  • +5 more secondary outcomes

Study Arms (2)

Epoetin alfa

EXPERIMENTAL

Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks

Drug: Group 1: Epoetin alfa

No treatment

PLACEBO COMPARATOR

Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks

Drug: Group 2: Placebo

Interventions

Group 2: PlaceboDRUG

form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks

No treatment
Group 1: Epoetin alfaDRUG

type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks

Epoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening
  • Documentation of an International Prognostic Scoring System score indicating Low- or Intermediate-1-risk disease within 12 weeks prior to screening
  • Hemoglobin concentration at screening and baseline (before the first dose of study drug) of 10.0 g/dL or less
  • Screening serum erythropoietin concentration of less than 500 mU/mL
  • Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell units over the last 8 weeks before randomization

You may not qualify if:

  • Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding)
  • Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation therapy/exposure)
  • History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ of the cervix or breast curatively treated
  • Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization
  • Prior use of approved or experimental agents for the treatment of MDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Varna, Bulgaria

Location

Unknown Facility

Amiens, France

Location

Unknown Facility

Angers, France

Location

Unknown Facility

Bobigny, France

Location

Unknown Facility

Colmar, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Pessac, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Saint-Priest-en-Jarez, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Duisburg, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Dÿsseldorf, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Oldenburg, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Goudi-Athens, Greece

Location

Unknown Facility

Larissa, Greece

Location

Unknown Facility

Pátrai, Greece

Location

Unknown Facility

Thessalonikis, Greece

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Yekaterinburg, Russia

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesMyeloproliferative DisordersBone Marrow DiseasesAnemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Janssen-Cilag International NV Clinical Trial

    Janssen-Cilag International NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

BU(3)GR(5)FR(10)DE(8)RU(2)