Clinical trials: sponsored by 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
Sars-CoV2
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19).
- Trial name
- NCT04411667
- Testing
- Octagam
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- George Sakoulas, MD
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
Dermatomyositis
Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS
- Trial name
- NCT03686969
- Testing
- Octanorm
- Where
- Russia
- Volunteers
- 1 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
Autoimmune Diseases
Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases
This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.
- Trial name
- NCT03656640
- Testing
- Gammanorm
- Where
- 3 sites in France, Martinique
- Volunteers
- 60 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
Severe Hemophilia A
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A
The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with…
- Trial name
- NCT02954575
- Testing
- Wilate
- Where
- 7 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 57 people
- Sponsor
- Octapharma
Severe Hemophilia A
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
- Trial name
- NCT01992549
- Testing
- Human-cl rhFVIII
- Where
- 15 sites in United States, Canada and 7 more
- Volunteers
- 48 people
- Sponsor
- Octapharma
Severe Haemophilia A
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses.
- Trial name
- NCT02256917
- Testing
- Human cl rhFVIII
- Where
- 30 sites in United States, Canada and 7 more
- Volunteers
- 58 people
- Sponsor
- Octapharma
Severe Hemophilia A
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
- Trial name
- NCT01712438
- Testing
- Human cl rhFVIII
- Where
- 37 sites in United States, Belarus and 15 more
- Volunteers
- 110 people
- Sponsor
- Octapharma
Severe Hemophilia A
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A
A prospective, non-controlled, international, multi-centre phase 3 study to investigate the pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated children with severe haemophilia A
- Trial name
- NCT03376516
- Testing
- Wilate
- Where
- 3 sites in Russia, Ukraine
- Volunteers
- 11 people
- Sponsor
- Octapharma
Von Willebrand Disease
Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
This is an observational study, hence there is no study hypothesis
- Trial name
- NCT01602419
- Testing
- Patients using Wilate as standard of care
- Where
- 24 sites in United States, Argentina and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
Congenital Fibrinogen Deficiency
Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less than 12 years of age.The planned study duration…
- Trial name
- NCT02408484
- Testing
- Octafibrin
- Where
- 4 sites in India, Iran and 1 more
- Volunteers
- 15 people
- Sponsor
- Octapharma
Congenital Fibrinogen Deficiency
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02267226
- Testing
- Octafibrin
- Where
- 12 sites in United States, Bulgaria and 7 more
- Volunteers
- 25 people
- Sponsor
- Octapharma
Primary Immunodeficiency
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01…
- Trial name
- NCT03907241
- Testing
- Octanorm 16.5%
- Where
- 7 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Octapharma
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma