Clinical Trials List
Protocol NumberM19-388
NCT Number(ClinicalTrials.gov Identfier)NCT03844048
2020-11-30 - 2025-05-27
Phase III
Recruiting1
Terminated1
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
-
Trial Applicant
AbbVie
-
Sponsor
AbbVie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tai-Chung Huang 無
- Wen-Chien Chou 無
- 徐思淳 無
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Chronic Lymphocytic Leukemia
Objectives
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.
Test Drug
Venetoclax
Active Ingredient
Venetoclax
Dosage Form
Tablet
Tablet
Tablet
Dosage
50
100
100
Endpoints
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.
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.
Inclution Criteria
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.
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
Exclusion Criteria:
- None.
- None.
The Estimated Number of Participants
-
Taiwan
7 participants
-
Global
550 participants
