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Multicenter open study to investigate the safety of weekly therapy with Neorecormon in anemic patients with malignant solid tumors.

Multicenter open study to investigate the safety of weekly therapy with Neorecormon in anemic patients with malignant solid tumors.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-042-04
Enrollment
10
Registered
2004-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

NeoRecormon® Type of group
NeoRecormon® will be given once a week

Sponsors

PRODUCTOS ROCHE Q.F.S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: * Adult patients diagnosed with solid malignant tumor with histological confirmation * Hemoglobin 6 months * Written informed consent.

Exclusion criteria

Exclusion criteria: * Transfusion of red blood cells during the 2 months prior to the first dose of the study medication. * High blood pressure resistant to treatment. * Relevant chronic or acute bleeding, which needed treatment within 3 months prior to the start of the study, example patient with anemia caused by gastrointestinal bleeding. * Anti-tumor therapy in the week prior to the screening visit apart from corticosteroids * Patients scheduled to receive bone marrow transplantation during the study period.

Design outcomes

Primary

MeasureTime frame
Outcome name:clinic history Measure:clinical evaluation of the efficacy of the drug Timepoints:3 semanas—

Secondary

MeasureTime frame
Outcome name:Adverse effects and laboratory alterations Measure:evaluation of the safety of the drug Timepoints:3 weeks—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)