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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: Completed Phase 2 study, sponsored by Ansun Biopharma.
NCT01740063 is a Phase 2 study that has completed, run by Ansun Biopharma. The registered enrollment target is 423 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (218% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Because of the possibility of unacceptable or excessive defined serious adverse events during the treatment period or the study enrollment period, a stopping rule for safety/tolerability has been introduced in the design. The following two stopping rule criteria will initiate an ad hoc DSMB data evaluation. * 5% with a related SAE post-dose Day 1 through Day 28 , or * 15% with related DAIDS toxicity Grade 3 and 4 laboratory abnormalities post-dose Day 1 through Day 28 * Grade 3 laboratory a
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 |
What the finished NCT01740063 record still lists
NCT01740063 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (218% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01740063 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01740063's enrollment target sits among peer trials
423 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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