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Clinical Trials/EUCTR2016-001464-11-IE
EUCTR2016-001464-11-IE
Active, not recruiting
Phase 1

ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX

Alnylam Pharmaceuticals, Inc.0 sites90 target enrollmentJuly 5, 2017
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ConditionsHemophilia A or Hemophilia BMedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000011915MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000011913Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hemophilia A or Hemophilia B
Sponsor
Alnylam Pharmaceuticals, Inc.
Enrollment
90
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2017
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Males \=12 years of age.
  • •Severe hemophilia A or B (evidenced by a central laboratory FVIII \<1% or FIX level \=2% at Screening) without inhibitors (evidenced by inhibitor titer of \<0\.6 BU/mL and supported by medical records)
  • •AT activity \=60% at Screening
  • •A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months
  • •Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of patients under the age of legal consent
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 8
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 77
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Patients with known co\-existing bleeding disorders other than hemophilia A or B
  • •Patients with clinically significant liver disease
  • •Patients known to be HIV positive and have a CD4 count \<200 cells/µL
  • •Patients with a history of arterial or venous thromboembolism
  • •Estimated glomerular filtration rate \=45 mL/min/1\.73m2 (using the Modification of Diet in Renal Disease \[MDRD] formula)
  • •Patients with a co\-existing thrombophilic disorder
  • •Patients with a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc
  • •Patients with a history of intolerance to SC injection(s)
  • •Patients with an anticipated or planned need for surgery during the study
  • •Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A study of fitusiran in hemophilia A and B patients without inhibitorsHemophilia A or Hemophilia BMedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2016-001464-11-DKGenzyme Corporation120
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A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitorsHemophilia A or Hemophilia BMedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2016-001464-11-HUAlnylam Pharmaceuticals, Inc.90
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A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitorsHemophilia A or Hemophilia BMedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2016-001464-11-NLAlnylam Pharmaceuticals, Inc.120
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A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitors
EUCTR2016-001464-11-PTGenzyme Corporation120
Active, not recruiting
Phase 1
A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitorsHemophilia A or Hemophilia BMedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2016-001464-11-GBGenzyme Corporation120