Trial record 1 of 1 for:
NCT02939118
One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™
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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: NCT02939118 |
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Recruitment Status :
Enrolling by invitation
First Posted : October 19, 2016
Last Update Posted : February 12, 2021
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Sponsor:
ViaCyte
Information provided by (Responsible Party):
ViaCyte
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | October 18, 2016 | ||
| First Posted Date | October 19, 2016 | ||
| Last Update Posted Date | February 12, 2021 | ||
| Actual Study Start Date | November 7, 2016 | ||
| Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Incidence of adverse events reported during the study. [ Time Frame: 12 months ] | ||
| Original Primary Outcome Measures |
Incidence of adverse events reported during the study. [ Time Frame: 36 months ] | ||
| Change History | |||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™ | ||
| Official Title | A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product | ||
| Brief Summary | The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product. | ||
| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | All subjects who have been exposed to implanted VC-01™ in any ViaCyte clinical trial. | ||
| Condition | Type 1 Diabetes Mellitus | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Enrolling by invitation | ||
| Estimated Enrollment |
200 | ||
| Original Estimated Enrollment | Same as current | ||
| Estimated Study Completion Date | November 2023 | ||
| Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT02939118 | ||
| Other Study ID Numbers | VC01-201 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | ViaCyte | ||
| Study Sponsor | ViaCyte | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | ViaCyte | ||
| Verification Date | February 2021 | ||