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Clinical Trials/EUCTR2016-001464-11-HU
EUCTR2016-001464-11-HU
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 14, 2017
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ConditionsHemophilia 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]

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
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 14, 2017
End Date
TBD
Last Updated
4 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: 10
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 105
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\. Known co\-existing bleeding disorders other than hemophilia A or B, ie, Von Willebrand's disease, additional factor deficiencies, or platelet disorders.
  • •2\. Current use of factor concentrates as regularly administered prophylaxis designed to prevent spontaneous bleeding episodes.
  • •3\. AT activity \<60% at Screening as determined by central laboratory measurement.
  • •4\. Presence of clinically significant liver disease, or as indicated by any of the conditions below:
  • •a. INR \>1\.2;
  • •b. ALT and/or AST \>1\.5× upper limit of normal reference range (ULN);
  • •c. Total bilirubin \>ULN (\>1\.5 ULN in patients with Gilbert's Syndrome);
  • •d. History of portal hypertension, esophageal varices, or hepatic encephalopathy;
  • •e. Presence of ascites by physical exam
  • •5\. Hepatitis C virus antibody positive, except patients with a history of HCV infection who meet both conditions a. and b.:

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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]
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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]
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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
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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: 100000011915MedDRA version: 20.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000011913Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2016-001464-11-IEAlnylam Pharmaceuticals, Inc.90