Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02027701 |
Recruitment Status :
Completed
First Posted : January 6, 2014
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 3, 2014 | |||
First Posted Date ICMJE | January 6, 2014 | |||
Results First Submitted Date ICMJE | July 9, 2018 | |||
Results First Posted Date ICMJE | October 2, 2018 | |||
Last Update Posted Date | October 2, 2018 | |||
Actual Study Start Date ICMJE | July 30, 2014 | |||
Actual Primary Completion Date | July 10, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Adverse Events (AEs) Per Infusion [ Time Frame: Up to 49 weeks ] | |||
Original Primary Outcome Measures ICMJE |
Overall rate of adverse events (AEs) per infusion - high-dose IgPro20 [ Time Frame: Up to 48 weeks ] Overall rate of AEs per infusion during high-dose IgPro20 treatment
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | |||
Official Title ICMJE | Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003 | |||
Brief Summary | This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy. Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn. The treatment duration will be up to 48 weeks, followed by a completion visit (week 49). |
|||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Biological: IgPro20 | |||
Study Arms ICMJE | Experimental: IgPro20
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Intervention: Biological: IgPro20
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
82 | |||
Original Estimated Enrollment ICMJE |
70 | |||
Actual Study Completion Date ICMJE | July 10, 2017 | |||
Actual Primary Completion Date | July 10, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States | |||
Removed Location Countries | Czech Republic, Finland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT02027701 | |||
Other Study ID Numbers ICMJE | IgPro20_3004 2013-004157-24 ( EudraCT Number ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | CSL Behring | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | CSL Behring | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | CSL Behring | |||
Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |