drugset / Trial / NCT01559818
A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
NaSingle-groupOpen-labelTreatment
Summary
Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study. Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken. The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days. The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.
Timeline
- Start
- 2012-02
- Primary completion
- 2019-07
- Completion
- 2019-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMM-101 | Other / unclassified | 1 mg | Other |