Darbepoetin Alfa MDS Companion Protocol

• Status: Completed
• Trial end date: 2017-03-20
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Subject or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/ procedures being initiated;

• Subject must continue long term follow up within parent study (20090160);

• Subject must have an ongoing clinically relevant erythroid response as assessed by the Investigator using current response criteria (ie, International Working Group (IWG) response criteria);

Exclusion Criteria:

• Transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell (RBC) transfusion in the previous 8-week period prior to enrolment;

• Known diagnosis of acute myelogenous leukemia (AML) or marrow collagen fibrosis;

• Known refractory anaemia with excess blast-2 (RAEB-2);

• Known diagnosis of intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS);

• Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in the MDS 20090160 study or planning to receive such agents during the study;

• Other protocol defined inclusion and exclusion criteria may apply.