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NCT01740063 · ClinicalTrials.gov registry record · Phase 2
Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
A Phase 2 study, sponsored by Ansun Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 423
- Enrollment target
NCT01740063 is a Phase 2 study that has completed, run by Ansun Biopharma. The registered enrollment target is 423 participants.
The verdict
NCT01740063, a Phase 2 study, has completed, sponsored by Ansun Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 423 participants
- Enrollment target
Study Summary
This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV). Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a placebo group. The modified intent to treat (mITT) analysis set will include subjects with confirmed influenza as documented by qPCR or TCID50. The full analysis set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Per protocol, the safety analysis sets are described below in statistical methods. A subpopulation of 60 participants will also have additional PK and Immunogenicity blood samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all study visits.
Interventions
- DRUG Placebo
- DRUG DAS181-F02 formulation
- DRUG DAS181-F04 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01740063
The ClinicalTrials.gov registry entry for NCT01740063 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ansun Biopharma, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01740063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01740063 about?
NCT01740063 is a clinical study titled "Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza". This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV). Subjects will be randomized into ...
What is the current status of trial NCT01740063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 423 participants. The study started on 2012-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01740063?
The interventions under investigation include: Placebo (DRUG), DAS181-F02 formulation (DRUG), DAS181-F04 formulation (DRUG).
Who is sponsoring clinical trial NCT01740063?
This trial is sponsored by Ansun Biopharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
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