Clinical trials: completed, sponsored by Octapharma
Chronic Lymphocytic Leukemia, Hypogammaglobulinemia
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
- Trial name
- NCT04502030
- Testing
- Panzyga
- Where
- 84 sites in United States, Czechia and 10 more
- Volunteers
- 247 people
- Sponsor
- Octapharma
Von Willebrand Disease
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age
The WIL-33 study aimed to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 paediatric patients (eight evaluable) with severe von Willebrand Disease VWD (defined as…
- Trial name
- NCT04953884
- Testing
- Wilate
- Where
- 9 sites in United States, Czechia and 5 more
- Volunteers
- 12 people
- Sponsor
- Octapharma
Pediatric Acute-Onset Neuropsychiatric Syndrome
Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS)
A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome
- Trial name
- NCT04508530
- Testing
- Panzyga
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 71 people
- Sponsor
- Octapharma
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
Covid-19
Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
- Trial name
- NCT04400058
- Testing
- Octagam 10%, Saline Solution
- Where
- 22 sites in United States, Russia and 1 more
- Volunteers
- 207 people
- Sponsor
- Octapharma
Von Willebrand Diseases
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
The purpose of this study is to prospectively obtain reliable data on the bleeding and treatment pattern of patients with VWD undergoing on-demand treatment with a VWF-containing product over a period of 6 months.
- Trial name
- NCT04053699
- Testing
- Von Willebrand Factor-Containing Product
- Where
- 15 sites in United States, Belarus and 6 more
- Volunteers
- 56 people
- Sponsor
- Octapharma
Primary Immune Deficiency Disorder
Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
- Trial name
- NCT03939533
- Testing
- CUTAQUIG
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Octapharma
Von Willebrand Diseases
Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD
This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy…
- Trial name
- NCT04052698
- Testing
- Wilate
- Where
- 14 sites in United States, Belarus and 6 more
- Volunteers
- 43 people
- Sponsor
- Octapharma
Covid19
Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
Multicentre, multinational, non-interventional, observational, retrospective, patient record study to evaluate changes in coagulation parameters in patients with severe COVID-19 infection receiving/not treatment with antithrombin…
- Trial name
- NCT04651400
- Testing
- Antithrombin III
- Where
- 6 sites in Austria, France and 2 more
- Volunteers
- 300 people
- Sponsor
- Octapharma
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Reversal of Anticoagulant Treatment
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
- Trial name
- NCT00618098
- Testing
- Octaplex (human prothrombin complex concentrate), Fresh frozen plasma
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Octapharma
Secondary Immune Deficiency
The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed.
- Trial name
- NCT03369301
- Testing
- Gammanorm, Other Subcutaneous Immunoglobulins
- Where
- 6 sites in France
- Volunteers
- 102 people
- Sponsor
- Octapharma
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Primary Immune Deficiency Disorder
Study of Octanorm Subcutaneous IG in Patients With PID
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections…
- Trial name
- NCT01888484
- Testing
- octanorm 16.5%
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 75 people
- Sponsor
- Octapharma
Emergency Care for Severe Bleeding While on Anticoagulants
Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or…
- Trial name
- NCT03320603
- Testing
- Expert eCRF, Prothrombin Complex Concentrate
- Where
- 26 sites in France
- Volunteers
- 397 people
- Sponsor
- Octapharma
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
- Trial name
- GAM 10-06 (NCT02303093)
- Testing
- Octagam IVIG 5% or 10%, Panzyga
- Where
- 38 sites in Austria, Canada and 3 more
- Volunteers
- 344 people
- Sponsor
- Octapharma
Bleeding
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.
- Trial name
- NCT04106895
- Testing
- Fibryga
- Where
- 5 sites in France
- Volunteers
- 200 people
- Sponsor
- Octapharma
Thrombotic Thrombocytopenic Purpura
Observational Study of the Use of octaplasLG®.
This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of…
- Trial name
- NCT03369314
- Testing
- octaplasLG®
- Where
- 14 sites in France
- Volunteers
- 263 people
- Sponsor
- Octapharma
Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
- Trial name
- CIDP (NCT02638207)
- Testing
- NewGam
- Where
- 26 sites in Bulgaria, Canada and 7 more
- Volunteers
- 142 people
- Sponsor
- Octapharma