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NCT02695160 · ClinicalTrials.gov registry record · Phase 1
Ascending Dose Study of Genome Editing by Zinc Finger Nuclease Therapeutic SB-FIX in Subjects With Severe Hemophilia B
A Phase 1 study, sponsored by Sangamo Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02695160: Clinical Trial Phase 1 study, sponsored by Sangamo Therapeutics.
NCT02695160 is a Phase 1 study that was terminated before completion, run by Sangamo Therapeutics. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02695160, a Phase 1 study, was terminated before completion, sponsored by Sangamo Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen and activity levels of ascending doses of SB-FIX. SB-FIX is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the Factor 9 gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production of the Factor IX clotting factor.
Primary Outcome
Number of Participants with Treatment Related Adverse Events in Subjects Who Received SB-FIX as Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Interventions
- BIOLOGICAL SB-FIX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-11-15 |
| Est. Completion | 2021-04-19 |
| Phase | Phase 1 |
Why NCT02695160 stopped before completion
NCT02695160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which SB-FIX is the first listed.
NCT02695160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02695160 about?
NCT02695160 is a clinical study titled "Ascending Dose Study of Genome Editing by Zinc Finger Nuclease Therapeutic SB-FIX in Subjects With Severe Hemophilia B". The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen and activity levels of ascending doses of SB-FIX. SB-FIX is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the Factor 9 gene into the albumin...
What is the current status of trial NCT02695160?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2016-11-15. Estimated completion is 2021-04-19.
What interventions are being tested in trial NCT02695160?
The interventions under investigation include: SB-FIX (BIOLOGICAL).
Who is sponsoring clinical trial NCT02695160?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02695160's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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