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Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03398434
Recruitment Status : Withdrawn (Trial cancelled before First Patient First Visit (no patient enrolled))
First Posted : January 12, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 12, 2018
Last Update Posted Date October 8, 2020
Estimated Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date November 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition [ Time Frame: month 3 ]
Occurrence of achieving ≥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
  • number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868 [ Time Frame: Month 1 and 2 ]
    Occurrence of achieving ≥ 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2
  • Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period. [ Time Frame: day 1 to day 91 ]
    Incidence of major or clinically relevant non-major bleeding events
  • the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator [ Time Frame: Days 31, 61 and 91 ]
    Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
Official Title  ICMJE A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation
Brief Summary The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized, open-label, blinded endpoint evaluation, active controlled, dose-range finding study.
Masking: Single (Outcomes Assessor)
Masking Description:
blinded (with majuscule) endpoint evaluation
Primary Purpose: Basic Science
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: MAA868
    3 MAA868 doses, single administration, subcutaneous,
  • Drug: Apixaban
    Apixaban 5 mg b.i.d
Study Arms  ICMJE
  • Experimental: MAA868 low dose regimen
    patients receive dose monthly.
    Intervention: Drug: MAA868
  • Experimental: MAA868 middle dose regimen
    patients receive dose monthly.
    Intervention: Drug: MAA868
  • Experimental: MAA868 high dose regimen
    patients receive dose monthly.
    Intervention: Drug: MAA868
  • Active Comparator: Apixaban
    Apixaban 5 mg b.i.d
    Intervention: Drug: Apixaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 3, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2018)
600
Estimated Study Completion Date  ICMJE January 30, 2020
Estimated Primary Completion Date November 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients ≥ 55 and < 85 years old
  • Body weight between 50 and 130 kg inclusive
  • Atrial fibrillation or atrial flutter, as documented by electrocardiography
  • CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
  • Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.

Exclusion Criteria:

  • History of stroke, transient ischemic attack or systemic embolism
  • History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
  • History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
  • Known bleeding diathesis or any known active bleeding site at screening or baseline
  • Family history of bleeding disorder
  • Known active GI lesions predisposing to bleeding events
  • Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period
  • Known hemodynamically significant valvular heart disease
  • Uncontrolled hypertension defined as SBP/DBP ≥ 160/100 mmHg at the screening visit
  • Heart failure NYHA class IV in the 3 months prior to the screening visit
  • Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both.
  • Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03398434
Other Study ID Numbers  ICMJE CMAA868A2202
2017-002741-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP