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Antihemophilic Medical Research Studies

Up-to-date List of Antihemophilic Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Antihemophilic Medical Research Studies

Rank Status Study
1 Recruiting An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
Intervention: Biological: Recombinant Factor VIII (rFVIII)
Outcome Measures: Treatment success;   Treatment success during the peri-operative surgical sub-study;   Inhibitor formation to FVIII;   AUC0-t;   AUC0-∞;   Percent of area extrapolated;   Cmax;   Tmax;   Elimination constant;   Half-life (t1/2);   AUMC0-∞;   Mean residence time (MRT);   Clearance (Cl);   Volume of distribution at steady-state (Vss);   Proportion of bleeding episodes;   Incremental recovery
2 Recruiting Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery
Condition: Hemophilia A
Intervention: Drug: Recombinant Protein-Free Factor VIII (rAHF-PFM)
Outcome Measures: Comparison of the cumulative packed red blood cell (PRBC) volume in the drainage fluid during 24 hours following surgery in subjects receiving rAHF-PFM by bolus infusion or continuous infusion;   Total amount of hemoglobin in the cumulative drainage fluid;   Actual postoperative blood loss;   Number of bleeding episodes during treatment with continuous or bolus infusion
3 Recruiting Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Condition: Severe Hemophilia A
Intervention: Drug: Alphanate SD/HT
Outcome Measures: Incidence of Factor VIII Inhibitor Development;   Adverse events;   Changes in biochemical parameters indicating renal or hepatic impairment;   Seroconversion to HIV/1, HIV/2, HAV, HBV, HCV or parvovirus B19 in subjects seronegative for these viruses at the time of enrollment;   Amount of product used per year as part of at-home prophylaxis and therapy for bleeding episodes;   Physician's qualitative assessment of hemostasis
4 Recruiting ADVATE Hemophilia A Outcome Database (AHEAD)
Condition: Hemophilia A
Intervention: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
Outcome Measures: Joint health outcomes - assessed by physical exam using only the pain, bleeding, and physical exam parameters of the Gilbert Scale.;   Annualized bleed rate, all joints;   Annualized bleed rate, all bleeds;   Annualized bleed rate, pre-existing target joints at baseline;   Incidence of New Target Joints;   Status of joint health by X-ray by Pettersson scale;   Status of Joint Health by Magnetic Resonance Imaging (MRI) Scoring System- Using The Lund Scoring System (LSS);   Status of joint health using the Hemophilia Joint Health Score (HJHS);   Overall effectiveness assessment for prophylaxis therapy;   Overall effectiveness assessment for on-demand treatment;   Global effectiveness assessment for on-demand treatment;   Number of ADVATE units required for bleed cessation;   Number of ADVATE infusions required for bleed cessation;   Incidence of target joint intervention, including surgery, radiosynovectomy, and chemosynovectomy;   Incidence of pseudo tumor development;   Quality of Life: HAL questionnaire - for adult patients;   Quality of Life: SF-12v2 questionnaire - for adult patients;   Quality of Life: EQ-5D questionnaire - for adult patients;   Quality of Life: PedHAL questionnaire - for pediatric patients;   Quality of Life: SF-10 questionnaire - for pediatric patients;   Quality of Life: EQ-5D (13 and up) questionnaire - for pediatric patients;   Chronic pain associated with hemophilia, as measured over a period of 4 weeks on an annual basis, using the visual analog scale (VAS);   Acute pain associated with hemophilia, as measured with individual bleeding episodes, using the visual analog scale (VAS);   Number of days lost from school or work due to bleeding episodes;   Incidence of Inhibitors in Previously Treated Patients (PTPs) with Factor VIII (FVIII) Levels <1%, ≤2%, and ≤5% without history of inhibitor;   Incidence of Inhibitors in Previously Treated Patients (PTPs) with Factor VIII (FVIII) Levels <1%, ≤2%, and ≤5% with history of inhibitor;   Incidence of Inhibitors in Previously Untreated Patient (PUPs) and Minimally Treated Patients (MTPs) with Factor VIII (FVIII) Levels <1%, ≤2%, and ≤5%;   Incidence of therapy-related serious adverse events;   Incidence of therapy-related non-serious adverse events
5 Recruiting ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)
Conditions: Hemophilia A;   Congenital Factor VIII (FVIII) Deficiency
Intervention: Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
Outcome Measures: Incidence of all local and general, hypersensitivity and infusion-related reactions, irrespective of product-related causality for the adverse events (AEs).;   Number and type of adverse events (or adverse experiences) (AEs) considered by the investigator to be causally related to ADVATE reconstituted in 2 mL sterile water for injection (SWFI);   Number of Factor VIII (FVIII) inhibitors in all participants;   Number of Factor VIII (FVIII) inhibitors in Previously Treated Patients (PTPs) (> 50 Exposure Days (EDs)) with baseline Factor VIII (FVIII) < 1% and no history of FVIII inhibitors prior to study entry;   Number of Factor VIII (FVIII) inhibitors in Previously Treated Patients (PTPs) (> 50 Exposure Days (EDs)) with baseline Factor VIII (FVIII) ≤ 2% and no history of FVIII inhibitors prior to study entry;   Subjective hemostatic effectiveness rating of excellent, good, fair, or none for each bleeding episode treated;   Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE reconstituted in 2 mL sterile water for injection (SWFI);   Total units of ADVATE reconstituted in 2 mL sterile water for injection (SWFI) administered to treat each bleeding episode;   Overall effectiveness of prophylaxis in participants who are on a prophylactic regimen;   Global assessment rating of hemostatic effectiveness of ADVATE reconstituted in 2 mL sterile water for injection (SWFI) in surgical or dental procedures;   Change in Factor VIII (FVIII) treatment satisfaction and preference ratings from caregiver between ADVATE reconstituted in 5 mL and 2 mL sterile water for injection (SWFI);   Change in Factor VIII (FVIII) infusion volume and time to mix and infuse FVIII treatment between ADVATE reconstituted in 5 mL and 2 mL sterile water for injection (SWFI)
6 Recruiting Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
Condition: Von Willebrand Disease
Intervention: Biological: Alphanate SD/HT
Outcome Measures: Assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures (mostly major surgeries).;   To assess the Day 0 (surgery day) and Day 1 (post-surgery day) treatment outcomes of each surgical procedure, rated by the investigator using a 2-point verbal rating scale.;   Assessment of Safety and Tolerability

These studies may lead to new treatments and are adding insight into Antihemophilic etiology and treatment.

A major focus of Antihemophilic research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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