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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Phase 3Panzyga-CIDPNCT03166527

Panzyga in CIDP Administered at Different Infusion Rates

A Phase 3 study testing Immune Globulin 10% Intravenous Solution in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by Vera Bril at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immune Globulin 10% Intravenous Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Jun 2017to 15 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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)
  • Hepatitis B, hepatitis C or HIV infection
  • 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
  • Body mass index (BMI) ≥40 kg/m2
  • Selective IgA deficiency with known anti-IgA antibodies
  • History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of panzyga®
  • Known blood hyperviscosity, or other hypercoagulable states
  • Use of other blood or plasma-derived products within three months prior to enrolment
  • Patients with a past or present history of drug abuse or alcohol abuse within the preceding five years prior to baseline visit
  • Patients unable or unwilling to understand or comply with the study protocol
  • Participation in another interventional clinical study with IMP treatment currently or during the three months prior to enrolment
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • UHNToronto

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

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

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.

Read the 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.
Being tested
Immune Globulin 10% Intravenous Solution
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune Globulin 10% Intravenous SolutionDrug

    Also called Panzyga IVIG

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

Study groups in NCT03166527
Study groupRoleWhat they receive
Open Label studyOtheropen label study using Panzyga immune globulin 10% intravenous solution with no placebo.
Receives: Drug: Immune Globulin 10% Intravenous Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    adverse drug reactions

    Measured: 2 years

Secondary outcomes (6)

  1. treatment satisfaction

    completion of questionnaire

    Measured: 2 years

  2. proportion of patients successfully achieving higher infusion rates

    descriptive analysis of number of patients

    Measured: 2 years

  3. health utilities

    completion of questionnaire

    Measured: 2 years

  4. proportion of responders to treatment based on change in clinical scores

    completion of scale

    Measured: 2 years

  5. grip strength

    measurements in kPa

    Measured: 2 years

  6. quality of life measures

    completion of scale

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2017
  2. Study start1 Jun 2017 (estimated)
  3. Primary completion15 Dec 2018 (estimated)
  4. Study completion15 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Each patient with active CIDP will receive Panzyga (immune globulin) at standard and high infusion rates and will act as their own control.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166527
Sponsor's protocol ID
1001
Acronym
Panzyga-CIDP
Status last verified
May 2017
First submitted
8 May 2017
Last updated
25 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immune Globulin 10% Intravenous Solution in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by Vera Bril at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of all adverse events with focus on adverse drug reactions (ADRs) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03166527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.

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