Trials / Completed
CompletedNCT01566695
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral Azacitidine | 300 mg daily, days 1 to 21 of each 28-day treatment cycle |
| DRUG | Placebo | Identically matching placebo tablets on day 1 to 21 of each 28-day treatment cycle. |
| OTHER | Best Supportiv Care (BSC) | BSC included and was not limited to packed RBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections. |
Timeline
- Start date
- 2013-04-26
- Primary completion
- 2019-01-25
- Completion
- 2023-12-21
- First posted
- 2012-03-29
- Last updated
- 2025-01-07
- Results posted
- 2020-02-26
Locations
196 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01566695. Inclusion in this directory is not an endorsement.