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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03166527
Date of registration: 08/05/2017
Prospective Registration: Yes
Primary sponsor: Vera Bril
Public title: Panzyga in CIDP Administered at Different Infusion Rates Panzyga-CIDP
Scientific 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
Date of first enrolment: June 1, 2017
Target sample size: 30
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03166527
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Canada
Contacts
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Intervention(s)
Drug: Immune Globulin 10% Intravenous Solution
Primary Outcome(s)
Occurrence of all adverse events with focus on adverse drug reactions (ADRs) [Time Frame: 2 years]
Secondary Outcome(s)
grip strength [Time Frame: 2 years]
health utilities [Time Frame: 2 years]
proportion of patients successfully achieving higher infusion rates [Time Frame: 2 years]
proportion of responders to treatment based on change in clinical scores [Time Frame: 2 years]
quality of life measures [Time Frame: 2 years]
treatment satisfaction [Time Frame: 2 years]
Secondary ID(s)
1001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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