Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
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|ClinicalTrials.gov Identifier: NCT01740063|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: DAS181-F02 formulation Drug: DAS181-F04 formulation Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||423 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Double-blind, Placebo-controlled Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: DAS181-F02 formulation
DAS181 10 mg dose for three days of the F02 formulation
Drug: DAS181-F02 formulation
Experimental: DAS181-F04 formulation
DAS181 20 mg dose group for three days of the F04 formulation,
Drug: DAS181-F04 formulation
Placebo Comparator: Placebo
- Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events [ Time Frame: Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013. ]
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 abnormalities in hematology or serum chemistry, excluding absolute neutrophils and absolute lymphocytes.
- Grade 4 laboratory abnormalities in hematology or serum chemistry including absolute neutrophils and absolute lymphocytes
Changes (absolute and percent) from baseline in influenza viral load from Day 1 to Day 2 as measured by quantitative polymerase chain reaction (qPCR) from pharyngeal wash and nasal wash samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740063
|United States, California|
|San Diego, California, United States, 92121|