Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03781414
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2018-12-18
Brief Title:
Study of Efficacy Safety Tolerability Pharmacokinetic PK and Pharmacodynamic PD of an Anti-CD40 Monoclonal Antibody CFZ533 in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 12-month Open-label Multicenter Randomized Safety Efficacy Pharmacokinetic PK and Pharmacodynamic PD Study of Two Regimens of Anti-CD40 Monoclonal Antibody CFZ533 vs Standard of Care Control in Adult de Novo Liver Transplant Recipients With a 12-month Additionalr Follow-up and a Long-term Extension CONTRAIL I
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated following less favorable efficacy by Iscalimab CFZ533 in liver transplant patients compared to tacrolimus
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTRAIL I
Brief Summary:
This was a multicenter open-label active-controlled study to evaluate the efficacy safety tolerability pharmacokinetics PK and pharmacodynamics PD of two CFZ533 maintenance doses in de novo liver transplant recipients
Detailed Description:
The study was designed as a randomized 36-month clinical trial comprised of
A screening period up to 2 months starting from informed consent screening visit and including successful liver transplantation LTx
A run-in treatment period following successful transplantation that ended on the day of randomization or randomization failure at Day 8 with visit window of - 2 days post-LTx
The primary treatment period Treatment Period 1 starting at randomization Day 8 - 2 post-LTx up to Month 12 followed by a 12-month follow-up treatment period Treatment Period 2 until Month 24
The long-term extension period Treatment Period 3 starting post Month 24 until the end of the study EOS
A minimum 12-week safety follow-up period for all patients after EOS
The study was terminated following less favorable efficacy by Iscalimab CFZ533 in liver transplant patients compared to tacrolimus
A screening period up to 2 months starting from informed consent screening visit and including successful liver transplantation LTx
A run-in treatment period following successful transplantation that ended on the day of randomization or randomization failure at Day 8 with visit window of - 2 days post-LTx
The primary treatment period Treatment Period 1 starting at randomization Day 8 - 2 post-LTx up to Month 12 followed by a 12-month follow-up treatment period Treatment Period 2 until Month 24
The long-term extension period Treatment Period 3 starting post Month 24 until the end of the study EOS
A minimum 12-week safety follow-up period for all patients after EOS
The study was terminated following less favorable efficacy by Iscalimab CFZ533 in liver transplant patients compared to tacrolimus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001836-24 | EUDRACT_NUMBER | None | None |
| CCFZ533A2202 | Other Identifier | Novartis | None |