NCT00560274

Brief Summary

This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_4

Geographic Reach
1 country

24 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

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

3.7 years

First QC Date

November 16, 2007

Last Update Submit

February 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

  • Blood pressure, pulse rate.

    6 and 12 months

  • AEs, and laboratory parameters.

    Throughout study

Secondary Outcomes (4)

  • Percentage of patients achieving correction of anemia

    3 months

  • Percentage of patients not requiring blood transfusion

    12 months

  • Course of Hb concentration

    12 months

  • Percentage of patients maintaining initial ribavirin dose

    12 months

Study Arms (1)

1

EXPERIMENTAL
Drug: PegasysDrug: RibavirinDrug: epoetin beta [NeoRecormon]

Interventions

PegasysDRUG

As prescribed

1
RibavirinDRUG

As prescribed

1
epoetin beta [NeoRecormon]DRUG

30,000 IU sc/week (starting dose)

1

Eligibility Criteria

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

You may qualify if:

  • adult patients, \>=18 years of age;
  • chronic hepatitis C;
  • quantifiable serum HCV RNA;
  • Pegylated interferon + ribavirin treatment started \<6 months before study;
  • Hb \<10g/dL.

You may not qualify if:

  • treatment with ESA during preceding 12 weeks;
  • poorly controlled hypertension;
  • history of cancer, except for basal cell cancer and cervical cancer in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Angers, 49933, France

Location

Unknown Facility

Besançon, 25030, France

Location

Unknown Facility

Caen, 14033, France

Location

Unknown Facility

Chambray-lès-Tours, 37171, France

Location

Unknown Facility

Clichy, 92118, France

Location

Unknown Facility

Créteil, 94000, France

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Limoges, 87042, France

Location

Unknown Facility

Lyon, 69437, France

Location

Unknown Facility

Marseille, 13285, France

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nice, 06202, France

Location

Unknown Facility

Paris, 75571, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Pessac, 33604, France

Location

Unknown Facility

Rennes, 35033, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Saint-Laurent-du-Var, 06721, France

Location

Unknown Facility

Strasbourg, 67091, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Tourcoing, 59208, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Anemia

Interventions

peginterferon alfa-2aRibavirinepoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

March 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

FR(24)