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Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP

This study is currently recruiting participants.
Verified August 2016 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT02549170
First Posted: September 15, 2015
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.

Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Biological: HYQVIA Biological: 0.25% albumin placebo solution with rHuPH20 Biological: IGIV Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Epoch 1: Relapse rate (proportion of participants who experience a worsening of functional disability) [ Time Frame: Screening; Pre-SC Baseline; AND participants on: 1) Q2W: week 15 & 27; End of Epoch 1 (EOE1); Unscheduled relapse visit assessment (UV); & if early termination occurs (ET). 2) Q3W: week 14 & 26; EOE1; UV; and ET. 3) Q4W: week 16 & 28; EOE1; UV; and ET. ]
    Worsening of functional disability defined as an increase of ≥1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale.

  • Epoch 2: Responder rate (proportion of participants with clinically meaningful improvement in functional ability) [ Time Frame: Epoch 2: Pre-IV Baseline and every 3 weeks through end of Epoch 2 (6 months) ]
    Clinically meaningful improvement in functional ability defined as a decrease of ≥1 point in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score


Secondary Outcome Measures:
  • Epoch 1: Time to relapse [ Time Frame: Throughout Epoch 1, up to 6 months ]
    Defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse

  • Epoch 1: Change from pre-subcutaneous (SC) treatment baseline in Rasch-built Overall Disability Scale (R-ODS) score [ Time Frame: Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs. ]
    The Rasch-Built Overall Disability Scale (R-ODS) is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The R-ODS is comprised of 24 items for which subjects are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.

  • Epoch 1: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion

  • Epoch 1: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 1: Number of participants who develop binding and/or neutralizing antibodies to Recombinant human hyaluronidase (rHuPH20) [ Time Frame: Throughout Epoch 1, up to 6 months ]
  • Epoch 2: Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants experiencing causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent serious and/or non-serious adverse events (SAEs and/or AEs), regardless of causality [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with causally related serious and/or non-serious adverse events (SAEs and/or AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions temporally associated with adverse events (AEs) [ Time Frame: During an infusion or within 72 hours after completion of an infusion ]
    AEs occurring during an infusion or within 72 hours after completion of an infusion

  • Epoch 2: Number of infusions associated with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent systemic adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions associated with treatment-emergent local infusion site reactions [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or adverse events (AEs) [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse events (AEs), regardless of causality, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of causally related systemic and local adverse events (AEs), expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per infusion [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 2: Rates of systemic and local adverse reactions (ARs) plus suspected ARs, expressed as number of events per participant-year [ Time Frame: Throughout Epoch 2, up to 6 months ]
  • Epoch 1: Proportion of participants who experience a worsening of functional disability [ Time Frame: Throughout Epoch 1, up to 6 months ]
    Defined as one or more of the following: an increase of ≥1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) worsening (defined as a ≥8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); ≥4 points decrease in Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period)

  • Epoch 2: Proportion of participants with clinically meaningful improvement in functional ability [ Time Frame: Throughout Epoch 2, up to 6 months ]
    Defined as one or more of the following: a decrease of ≥1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; ≥4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score


Estimated Enrollment: 232
Study Start Date: December 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoch 1: HYQVIA/HyQvia
HYQVIA/HyQvia contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20)
Biological: HYQVIA
Dosing regimen for HYQVIA/HyQvia will be the same as the participant's pre-randomization monthly equivalent IgG dose when administered every 2, 3, or 4 weeks.
Other Names:
  • IGI
  • 10% with rHuPH20
  • Immune Globulin Infusion 10% (Human) (IGI
  • 10%) with recombinant human hyaluronidase (rHuPH20)
Placebo Comparator: Epoch 1: Placebo with rHuPH20
Placebo treatment consists of a placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20
Biological: 0.25% albumin placebo solution with rHuPH20
Dosing regimen for placebo treatment will be the same as the participant's pre-randomization monthly equivalent IgG infusion volume when administered every 2, 3, or 4 weeks.
Experimental: Epoch 2: IGIV
Intravenous immunoglobulin G treatment
Biological: IGIV
IGIV treatment will consist of an induction dose of 2 g/kg, followed by maintenance infusions at the same monthly dose as the participant's pre-randomization IgG dose, every 3 weeks.
Other Names:
  • Immune Globulin Infusion (Human)
  • 10% Solution
  • KIOVIG
  • IVIg
  • Approved IGIV product for US sites
  • GAMMAGARD LIQUID
  • Intravenous immunoglobulin G

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded) consistent with European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria.
  2. Participant has responded to IgG treatment in the past, (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of intravenous immunoglobulin G (IGIV) treatment at monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks for at least 3 months prior to screening.
  3. Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1, or 2 (if at least 1 point is from an upper extremity) must have a history of significant disability - ie, INCAT disability score of 2 (must be exclusively from the lower extremities) or greater in the past 24 months.
  4. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product.
  5. Participant is willing and able to sign an Informed Consent Form (ICF).
  6. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Focal atypical CIDP or pure sensory atypical CIDP.
  2. Any neuropathy of other causes, including:

    1. Hereditary demyelinating neuropathies
    2. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria; systemic lupus erythematosus; polyneuropathy, organomegaly, endocrinopathy or edema, M-protein, skin changes (POEMS) syndrome; osteosclerotic myeloma; diabetic and non-diabetic lumbosacral radiculoplexus neuropathy; lymphoma, and amyloidosis
    3. Multifocal motor neuropathy (MMN)
    4. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy
  3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein
  4. Prominent sphincter disturbance.
  5. Central demyelinating disorders (eg, multiple sclerosis).
  6. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed.)
  7. Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg).
  8. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months.
  9. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
  10. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m^2 estimated based on CKD-EPI equation (2009).
  11. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
  12. Clinically significant anemia or hemoglobin (Hgb) level of <10.0 g/dL at screening.
  13. Hypersensitivity or adverse reactions (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.
  14. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
  15. Known history of or immunoglobulin A (IgA) deficiency (<8 mg/dL) at screening.
  16. Abnormal laboratory values at screening:

    1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN)
    2. Platelet count <100,000 cells/µL
    3. Absolute neutrophil count (ANC) <1000 cells/µL
  17. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection.
  18. Use of immunomodulatory/immunosuppressive agents in the past 6 months (stable, low-dose systemic corticosteroids (≤10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids are allowed).
  19. Participant has received or is currently receiving treatment with corticosteroids within 3 months prior to screening. The following exceptions for prednisolone or its equivalent are allowed: stable dosages of low-dose systemic corticosteroids (≤10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids (eg, topical, ophthalmic, or inhaled glucocorticoids). In addition and for the purpose of treating AE or non-CIDP intercurrent disease, a single corticosteroid dose >10 mg prednisolone or a single short term course of ≤ to 7 days (such as Methylprednisolone Dose Pack) within 3 months prior to screening is allowed.
  20. Participant has undergone plasma exchange within 3 months prior to screening.
  21. The participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
  22. The participant is nursing or intends to begin nursing during the course of the study.
  23. Participation in another clinical study involving an investigational product and/or device within 30 days prior to enrollment, or planned participation in another clinical study during the course of this study.
  24. The participant is a family member or employee of the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549170


Contacts
Contact: Andras Nagy 617-588-8362 andras.nagy@baxalta.com

Locations
Canada, Quebec
Recherche Sepmus, Inc. Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal Neurological Institute Clinical Research Unit Recruiting
Montréal, Quebec, Canada, H3A 2B4
Czech Republic
Fakultni nemocnice Ostrava Recruiting
Ostrava - Poruba, Czech Republic, 708 52
Fakultni nemocnice v Motole Recruiting
Prague 5, Czech Republic, 150 06
Vseobecna fakultni nemocnice v Praze Recruiting
Praha 2, Czech Republic, 128 21
Denmark
Aarhus Universitetshospital Recruiting
Aahus C, Denmark, 8000
France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin Recruiting
Bordeaux Cedex, Gironde, France, 33076
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Fondazione PTV - Policlinico Tor Vergata Recruiting
Pozzilli, Isernia, Italy, 86077
Azienda Ospedaliera Universitaria Policlinico G. Martino Recruiting
Messina, Italy, 98122
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56126
Spain
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Sweden
Sahlgrenska universitetssjukhuset Recruiting
Goteborg, Sweden, 413 45
United Kingdom
King's College Hospital Recruiting
London, Greater London, United Kingdom, SE5 9RS
The Walton Centre Recruiting
Liverpool, Merseyside, United Kingdom, L9 7LJ
Sponsors and Collaborators
Shire
Investigators
Study Director: David Gelmont, MD Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02549170     History of Changes
Other Study ID Numbers: 161403
First Submitted: September 11, 2015
First Posted: September 15, 2015
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Shire:
Autoimmune Diseases
Polyneuropathies
Nervous System Diseases
Peripheral Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Immunoglobulins
Immune System Diseases
Demyelinating Diseases
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Neuromuscular Diseases

Additional relevant MeSH terms:
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs