Status: Recruiting

Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks

Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks

Participants needed: 124

Trial details

Phase: Phase 3Age: 2+Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: Jun 30, 2026Locations: 21

Eligibility criteria

Is at least 18 years of age (applicable for 1st study phase) or is at least 2 ye... [+14]

Has a history of clinically relevant antibody development against C1-INH [+22]

Status: Not yet recruiting

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy

Participants needed: 360

Trial details

Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: Jun 17, 2026

Eligibility criteria

Are ≥18 years of age at time of informed consent, have been diagnosed with a rhe... [+3]

Have a history of anaphylaxis or severe systemic response to immunoglobulin, blo... [+16]

Status: Recruiting

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.

Participants needed: 38

Trial details

Phase: Phase 3Age: 12-80Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: Jun 3, 2026Locations: 30

Eligibility criteria

Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male... [+5]

Requires emergency surgery or emergency caesarean section [+15]

Status: Recruiting

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Participants needed: 200

Trial details

Biological sex: AllType: ObservationalSponsor: OctapharmaUpdated: Jun 2, 2026Locations: 59

Eligibility criteria

Male and female patients of any age and ethnicity [+9]

Diagnosis with a coagulation disorder other than haemophilia A [+3]

Status: Recruiting

Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)

Participants needed: 120

Trial details

Phase: Phase 3Age: 18-85Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: May 12, 2026Locations: 27

Eligibility criteria

Planned cardiac surgery with CPB [+4]

vitamin K antagonists (within 3 days) [+12]

Status: Recruiting

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Participants needed: 28

Trial details

Phase: Phase 4Age: 12+Biological sex: MaleType: InterventionalSponsor: OctapharmaUpdated: May 12, 2026Locations: 18

Eligibility criteria

Severe haemophilia A (FVIII activity [FVIII:C] <1%) according to medical history [+4]

Coagulation disorder other than haemophilia A [+6]

Status: Recruiting

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Participants needed: 28

Trial details

Phase: Phase 4Age: 12+Biological sex: FemaleType: InterventionalSponsor: OctapharmaUpdated: May 12, 2026Locations: 16

Eligibility criteria

Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history. A... [+3]

Coagulation disorder other than haemophilia A [+7]

Status: Recruiting

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Participants needed: 3,574

Trial details

Age: 18+Biological sex: AllType: ObservationalSponsor: OctapharmaUpdated: Jun 4, 2025Locations: 1

Eligibility criteria

Subjects at least 18 years of age. [+2]

History of TEE within 90 days before receipt of VKA reversal therapy. [+1]

Status: Recruiting

Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients

Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients

Participants needed: 30

Trial details

Phase: Phase 3Age: 2-17Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: Jun 6, 2025Locations: 6

Eligibility criteria

Age ≥2 years and ≤17 years. [+3]

Patients with previously diagnosed CIDP who lack any CIDP symptoms. [+14]

Clinical trials

Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients