An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 165
- Locations
- 111
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
Brief Summary
The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
- •Male subject agrees to refrain from sperm donation.
- •Female subjects must not be pregnant or breastfeeding.
Exclusion Criteria
- Not provided
Arms & Interventions
Venetoclax
Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.
Intervention: Venetoclax (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported