Panzyga in CIDP Administered at Different Infusion Rates (Panzyga-CIDP)
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|ClinicalTrials.gov Identifier: NCT03166527|
Recruitment Status : Unknown
Verified May 2017 by Vera Bril, University Health Network, Toronto.
Recruitment status was: Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)||Drug: Immune Globulin 10% Intravenous Solution||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Estimated Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 15, 2018|
|Estimated Study Completion Date :||December 15, 2018|
Open Label study
open label study using Panzyga immune globulin 10% intravenous solution with no placebo.
Drug: Immune Globulin 10% Intravenous Solution
standard Immune lobulin 10% intravenous solution infusion at standard and high infusion rates.
Other Name: Panzyga IVIG
- Occurrence of all adverse events with focus on adverse drug reactions (ADRs) [ Time Frame: 2 years ]adverse drug reactions
- treatment satisfaction [ Time Frame: 2 years ]completion of questionnaire
- proportion of patients successfully achieving higher infusion rates [ Time Frame: 2 years ]descriptive analysis of number of patients
- health utilities [ Time Frame: 2 years ]completion of questionnaire
- proportion of responders to treatment based on change in clinical scores [ Time Frame: 2 years ]completion of scale
- grip strength [ Time Frame: 2 years ]measurements in kPa
- quality of life measures [ Time Frame: 2 years ]completion of scale
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): NCT03166527
|Toronto, Ontario, Canada, M5G 2C4|