Phase 2, open-label, single-arm rollover study to evaluate long-term Safety in subjects who participated in other Celgene sponsored CC-486 (oral Azacitidine) clinical trials in Hematological disorders

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503272-25-00

Acronym

CC-486-GEN-001

Enrollment

Registered

2023-09-07

Start date

Unknown

Completion date

2025-04-14

Last updated

2024-05-28

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

Conditions

Hematological Disorders

Brief summary

Safety: type, frequency, severity, and relationship of treatment emergent adverse events (AEs) to investigational product (CC-486).

Detailed description

Survival: time from randomization until death from any cause.

Interventions

DRUGazacitidine 200 mg tablet

DRUGazacitidine 150 mg tablet

DRUGazacitidine 300 mg tablet

DRUGazacitidine 100 mg tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety: type, frequency, severity, and relationship of treatment emergent adverse events (AEs) to investigational product (CC-486).	—

Secondary

Measure	Time frame
Survival: time from randomization until death from any cause.	—

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026