An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
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|ClinicalTrials.gov Identifier: NCT03844048|
Recruitment Status : Enrolling by invitation
First Posted : February 18, 2019
Last Update Posted : November 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Acute Myeloid Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma Acute Lymphoblastic Leukemia Cancer||Drug: Venetoclax||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial|
|Actual Study Start Date :||September 6, 2019|
|Estimated Primary Completion Date :||May 26, 2025|
|Estimated Study Completion Date :||May 26, 2025|
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
oral; film-coated tablets or tablets for oral suspension
- Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years). ]An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844048
|Study Director:||ABBVIE INC.||AbbVie|