Trials / Completed
CompletedNCT02027701
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IgPro20 |
Timeline
- Start date
- 2014-07-30
- Primary completion
- 2017-07-10
- Completion
- 2017-07-10
- First posted
- 2014-01-06
- Last updated
- 2018-10-02
- Results posted
- 2018-10-02
Locations
33 sites across 11 countries: United States, Australia, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02027701. Inclusion in this directory is not an endorsement.