Trial record 2 of 5 for:    rFVIIIFc

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01181128
First received: August 12, 2010
Last updated: September 12, 2013
Last verified: November 2012

August 12, 2010
September 12, 2013
November 2010
August 2012   (final data collection date for primary outcome measure)
  • Clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • • Clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • • Annualized number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01181128 on ClinicalTrials.gov Archive Site
  • Total annualized rFVIIIFc consumption per subject [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of PK parameter estimates of rFVIIIFc and rFVIII [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of subject's response to treatment [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of rFVIIIFc used in a surgical subgroup [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • • Total annualized rFVIIIFc consumption per subject [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • • Evaluation of PK parameter estimates of rFVIIIFc and rFVIII at baseline and at Week 12-28 [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • • Evaluation of subject's response to treatment [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
ALONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

The study is to investigate safety, pharmacokinetics (the determination of the concentration of drug in blood over time) and efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated subjects with severe hemophilia A

The current hemophilia standard of care for the prevention of bleeds and arthropathy is to maintain FVIII activity level above 1%. Due to the short half-life of the current FVIII products, prophylaxis therapy will require injection of 2-3 times per week or every other day. Treatment usually involves intravenous access, an invasive procedure, especially difficult in children. Episodic treatment will involve 1-3 injections to treat bleeding episodes, depending on the severity of the hemorrhage. Severe hemophilia patients will treat prophylactically with the long-lasting recombinant factor VIII Fc fusion protein (rFVIIIFc) in an interval to maintain FVIII activity level above 1%. Any bleeding episodes will be reported. The response to treatment will also be recorded to access the effectiveness of the rFVIIIFc.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Hemophilia A
Drug: rFVIIIFc
IV administration
  • Experimental: A
    Individualized Prophylaxis
    Intervention: Drug: rFVIIIFc
  • Experimental: B
    Weekly Prophylaxis
    Intervention: Drug: rFVIIIFc
  • Experimental: C
    Episodic (on demand) treatment
    Intervention: Drug: rFVIIIFc
Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, Hanabusa H, Gupta N, Kulkarni R, Fogarty P, Perry D, Shapiro A, Pasi KJ, Apte S, Nestorov I, Jiang H, Li S, Neelakantan S, Cristiano LM, Goyal J, Sommer JM, Dumont JA, Dodd N, Nugent K, Vigliani G, Luk A, Brennan A, Pierce GF; A-LONG Investigators. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan 16;123(3):317-25. doi: 10.1182/blood-2013-10-529974. Epub 2013 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male, ≥12 years of age and weigh at least 40 kg
  • Diagnosed with severe hemophilia A defined as <1 IU/dL (<1%) endogenous Factor VIII)
  • History of at least 150 documented prior exposure days to any Factor VIII product
  • Platelet count ≥100,000 cells/μL

Exclusion Criteria:

  • History of Factor VIII inhibitors
  • Kidney and liver dysfunction
  • Diagnosed with other coagulation disorder(s) other than hemophilia A
  • Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Hong Kong,   India,   Israel,   Italy,   Japan,   New Zealand,   Poland,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01181128
997HA301
Yes
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
November 2012

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