Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/4/2018 |
| Start Date: | July 30, 2014 |
| End Date: | July 10, 2017 |
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
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relapse within 4 weeks, they will be withdrawn.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).
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relapse within 4 weeks, they will be withdrawn.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).
Inclusion Criteria:
- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
rescued from a CIDP relapse during the SC Treatment Period of pivotal study
IgPro20_3003 (NCT01545076).
- Written informed consent for study participation obtained before undergoing any
study-specific procedures.
Exclusion Criteria:
- Subject is unable to directly transition from study IgPro20_3003.
- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
during participation in study IgPro20_3003 that in the judgment of the investigator
could increase risk to the subject, interfere with the evaluation of investigational
medicinal product, and/or conduct of the study.
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