Panzyga in CIDP Administered at Different Infusion Rates

NCT03166527 | Unknown Phase 3

• 1 other identifier: 1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a treatable form of peripheral neuropathy with suspected autoimmune cause. The current first-line treatment is IVIG (immune globulin), which is infused in a set regimen that requires 4-5 hours in a hospital day unit, taking up resources such as nursing time and hospital space. Chronic treatment is required in most cases.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Outcome Measures

Primary Outcomes (1)

• Occurrence of all adverse events with focus on adverse drug reactions (ADRs)

  adverse drug reactions

  2 years

Secondary Outcomes (6)

• treatment satisfaction

  2 years

• proportion of patients successfully achieving higher infusion rates

  2 years

• health utilities

  2 years

• proportion of responders to treatment based on change in clinical scores

  2 years

• grip strength

  2 years

Study Arms (1)

Open Label study

OTHER

open label study using Panzyga immune globulin 10% intravenous solution with no placebo.

Drug: Immune Globulin 10% Intravenous Solution

Interventions

Immune Globulin 10% Intravenous Solution DRUG

standard Immune lobulin 10% intravenous solution infusion at standard and high infusion rates.

Also known as: Panzyga IVIG

Open Label study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of definite or probable CIDP according to the EFNS/PNS Guideline 2010; including patients with Multifocal Acquired Demyelinating Sensory And Motor Neuropathy (MADSAM) or pure motor CIDP
• Patients with active disease, i.e. not being in remission.
• IVIG naïve patients with clinical indication for IVIG based on progressive or relapsing disease and adjusted INCAT (ONLS) disability score between 2 and 9 (with a score of 2 coming exclusively from leg disability).
• Patients already receiving IVIG must be on 3- or 4-weekly IVIG treatment schedule with a calculated monthly dosage between 0.8 g/kg and 2.0 g/kg BW
• ≥ 18 years of age
• Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted
• For enrolment into the Second Phase: At each of the last three infusions in the First Phase, administration of panzyga® had to be at the maximum infusion rate of 0.08 mL/kg/min and good tolerated- assessment by Investigator according to local site practice

You may not qualify if:

• MMN with conduction block
• Patients who previously failed immunoglobulin therapy
• Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to baseline visit
• Patients on or treated with rituximab, alemtuzumab, cyclophosphamide, or other intensive chemotherapeutic regimens, previous lymphoid irradiation or stem cell transplantation during the 12 months prior to baseline visit
• Respiratory impairment requiring mechanical ventilation
• Myelopathy or evidence of central nervous system demyelination or significant persisting neurological deficits from stroke, or central nervous system (CNS) trauma
• Clinical evidence of peripheral neuropathy from another cause such as
• connective tissue disease or systemic lupus erythematosus (SLE)
• HIV infection, hepatitis, Lyme disease
• cancer (with the exception of basal cell skin cancer)
• IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
• Diabetic neuropathy
• Cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
• Severe liver disease (ALAT 3x \> normal value)
• Severe kidney disease (creatinine 1.5x \> normal value)

Sponsors & Collaborators

• Vera Bril: lead

Study Sites (1)

UHNToronto

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Each patient with active CIDP will receive Panzyga (immune globulin) at standard and high infusion rates and will act as their own control.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 25, 2017
• Study Start: June 1, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)