Panzyga in CIDP Administered at Different Infusion Rates

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Brief Title

Panzyga in CIDP Administered at Different Infusion Rates

Official Title

Prospective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion Rates

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.
    

Detailed Description

      The proposed trial will be an exploratory, open-label, single-centre, phase IIIb safety,
      tolerability and efficacy study, wherein each patient acts as their own control. The primary
      outcome measure is safety and tolerability of panzyga in patients with active CIDP at
      standard and high infusion rates as measured by:

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

        -  The secondary outcomes include: Patients' treatment satisfaction, proportion of patients
           successfully achieving higher infusion rates, health utilities associated with
           treatment, proportion of responders to treatment based on change in clinical scores,
           grip strength, and quality of life measures. The total sample size is 25-30 patients,
           based on a difference of 30% in adverse events rates between the standard infusion rate
           and the maximum rate tolerated by each patient.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 treatment satisfaction

Condition

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Intervention

Immune Globulin 10% Intravenous Solution

Study Arms / Comparison Groups

 Open Label study
Description:  open label study using Panzyga immune globulin 10% intravenous solution with no placebo.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

June 1, 2017

Completion Date

December 15, 2018

Primary Completion Date

December 15, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. 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

          2. Patients with active disease, i.e. not being in remission.

          3. 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).

          4. 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

          5. ≥ 18 years of age

          6. Voluntarily given, fully informed written consent obtained from patient before any
             study-related procedures are conducted

          7. 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

        Exclusion Criteria:

          1. MMN with conduction block

          2. Patients who previously failed immunoglobulin therapy

          3. Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate,
             mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to
             baseline visit

          4. 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

          5. Respiratory impairment requiring mechanical ventilation

          6. Myelopathy or evidence of central nervous system demyelination or significant
             persisting neurological deficits from stroke, or central nervous system (CNS) trauma

          7. Clinical evidence of peripheral neuropathy from another cause such as

               1. connective tissue disease or systemic lupus erythematosus (SLE)

               2. HIV infection, hepatitis, Lyme disease

               3. cancer (with the exception of basal cell skin cancer)

               4. IgM paraproteinemia with anti-myelin associated glycoprotein antibodies

          8. Diabetic neuropathy

          9. Cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy,
             significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic
             heart disease

         10. Severe liver disease (ALAT 3x > normal value)

         11. Severe kidney disease (creatinine 1.5x > normal value)

         12. Hepatitis B, hepatitis C or HIV infection

         13. Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within
             the last year prior to baseline visit or pulmonary embolism ever; patients with
             susceptibility to embolism or DVT

         14. Body mass index (BMI) ≥40 kg/m2

         15. Selective IgA deficiency with known anti-IgA antibodies

         16. History of hypersensitivity, anaphylaxis or severe systemic response to
             immuno-globulin, blood or plasma derived products, or any component of panzyga®

         17. Known blood hyperviscosity, or other hypercoagulable states

         18. Use of other blood or plasma-derived products within three months prior to enrolment

         19. Patients with a past or present history of drug abuse or alcohol abuse within the
             preceding five years prior to baseline visit

         20. Patients unable or unwilling to understand or comply with the study protocol

         21. Participation in another interventional clinical study with IMP treatment currently or
             during the three months prior to enrolment

         22. Women who are breast feeding, pregnant, or planning to become pregnant, or are
             unwilling to use an effective birth control method (such as implants, injectables,
             combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or
             vasectomized partner) while on study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03166527

Organization ID

1001


Responsible Party

Sponsor-Investigator

Study Sponsor

Vera Bril


Study Sponsor

, , 


Verification Date

May 2017