ParainfluenzaPhase 2DAS181-2-05NCT01644877
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen
A Phase 2 study testing DAS181 dry powder, formulation F02 in people with Parainfluenza, run by Ansun Biopharma, Inc. at 45 sites in United States.
Trial summary
This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Parainfluenza
- What is being tested?
- DAS181 dry powder, formulation F02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 45 sitesUnited States
- Study dates
- Mar 2014to 15 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years
- Able to provide informed consent, child assent with parental consent or surrogate consent when applicable
- Currently on invasive mechanical ventilation or noninvasive positive pressure ventilation (CPAP or bilevel positive airway pressure) or requiring > 2LPM supplemental oxygen therapy to maintain O2 saturation > 90% due to hypoxemia
- Immunocompromised, as defined by one of the following: Autologous or Allogeneic hematopoietic cell transplantation (HSCT); Lung or lung-heart transplantation; Subjects treated with chemotherapy for hematologic malignancies; Subjects treated with chemotherapy for solid tumor malignancies
- Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (DFA), Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
- Confirmed PIV lower tract disease for subjects on mechanical ventilation will be defined as PIV detection in bronchoalveolar lavage (BAL) or biopsy within last 7 days of screening
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- Confirmed PIV lower tract disease for subjects on non-invasive positive pressure ventilation or supplemental oxygen will be defined as all of the following within the last 7 days of screening: New pulmonary infiltrate on chest imaging and at least one PIV sign and/or symptom as defined in section 10.3.6
- Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
- Male subjects must agree to use medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.
Who cannot join
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
- Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
- In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
- Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
- Subjects with a history of RSV or MPV
- Subjects taking any other investigational drug used to research or treat PIV.
- Subjects with a history of allergic reactions to lactose.
- Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Lurie Children's Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Nationwide Children's
Columbus, Ohio, 43205
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 42367
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Kansas, 64108
University of Kansas
Kansas City, Kansas, 66160
Loyola University Medical Center
Maywood, Illinois, 60153
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Minnesota, School of Medicine
Minnesota City, Minnesota, 55455
Vanderbilt- Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021
Weill Cornell Medical College-Peds
New York, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Stanford University Medical Center
Palo Alto, California, 94305
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic-Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
UC Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84108
Ansun Biopharma, Inc
San Diego, California, 92121
Seattle Children's Hospital
Seattle, Washington, 98105
Fred Hutchinson Cencer Research Center
Seattle, Washington, 98109-1024
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Stonybrook
Stony Brook, New York, 11794-88183
Montefiore Medical Center
The Bronx, New York, 10461
About this study
This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
- Conditions
- Parainfluenza
- Being tested
- DAS181 dry powder, formulation F02, Lactose Placebo
- Medical subject headings
- Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181 dry powder, formulation F02Drug
Lactose PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DAS181 | Experimental | DAS181-F02, 4.5 mg qd x 10 days Receives: Drug: DAS181 dry powder, formulation F02 |
| Lactose Placebo | Placebo comparator | placebo, 4.5 mg qd x 10 days Receives: Drug: Lactose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Stability
Clinical stability survival (CSS) rate is defined as subjects who meet the clinical stability criteria and are alive at Study Day 45 (Responders) compared to those who have not met clinical stability criteria or have expired regardless of stability status (Non-responders)
Measured: 45 days
Secondary outcomes (5)
Clinical Stability
Clinical stability (CS) rate excluding survival status: Clinical stability (CS) rate is defined as subjects who reached clinical stability criteria (Responders) compared to those subjects who did not meet the clinical stability criteria (Non-responders).
Measured: 45 days
Mortality
Mortality rate at Day 45
Measured: 45 days
Clinical Stability
Time (in days) to reach clinical stability (including survival status or excluding survival status)
Measured: 45 days
Clinical Stability
Time (in days) to death
Measured: 45 days
Clinical Stability
Time (in days) to hospital discharge of CS non-responders and death
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMar 2014
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParainfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644877
- Sponsor's protocol ID
- DAS181-2-05
- Acronym
- DAS181-2-05
- Status last verified
- Sep 2017
- First submitted
- 17 Jul 2012
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chemaly RF, Marty FM, Wolfe CR, Lawrence SJ, Dadwal S, Soave R, Farthing J, Hawley S, Montanez P, Hwang J, Ho JH, Lewis S, Wang G, Boeckh M. DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study. Clin Infect Dis. 2021 Aug 2;73(3):e773-e781. doi: 10.1093/cid/ciab113.
PubMed 33569576
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen
- ClinicalTrials.gov ID
- NCT01644877
- Acronym / sponsor ID
- DAS181-2-05 / DAS181-2-05
- Conditions
- Parainfluenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAS181 | Experimental | Drug: DAS181 dry powder, formulation F02DAS181-F02, 4.5 mg qd x 10 days |
| Lactose Placebo | Placebo comparator | Drug: Lactose Placeboplacebo, 4.5 mg qd x 10 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥12 years
- Able to provide informed consent, child assent with parental consent or surrogate consent when applicable
- Currently on invasive mechanical ventilation or noninvasive positive pressure ventilation (CPAP or bilevel positive airway pressure) or requiring > 2LPM supplemental oxygen therapy to maintain O2 saturation > 90% due to hypoxemia
- Immunocompromised, as defined by one of the following: Autologous or Allogeneic hematopoietic cell transplantation (HSCT); Lung or lung-heart transplantation; Subjects treated with chemotherapy for hematologic malignancies; Subjects treated with chemotherapy for solid tumor malignancies
- Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (DFA), Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
Key exclusion criteria (8 listed)
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
- Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
- In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
- Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
- Subjects with a history of RSV or MPV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAS181 dry powder, formulation F02 | Drug | DAS181 |
| Lactose Placebo | Drug | Lactose Placebo |
Primary outcome
Clinical Stability
Time frame: 45 days
Clinical stability survival (CSS) rate is defined as subjects who meet the clinical stability criteria and are alive at Study Day 45 (Responders) compared to those who have not met clinical stability criteria or have expired regardless of stability status (Non-responders)
5 secondary outcomes
Clinical Stability
Time frame: 45 days
Mortality
Time frame: 45 days
Clinical Stability
Time frame: 45 days
Clinical Stability
Time frame: 45 days
Clinical Stability
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 33569576Chemaly RF, Marty FM, Wolfe CR, Lawrence SJ, Dadwal S, Soave R, Farthing J, Hawley S, Montanez P, Hwang J, Ho JH, Lewis S, Wang G, Boeckh M. DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study. Clin Infect Dis. 2021 Aug 2;73(3):e773-e781. doi: 10.1093/cid/ciab113.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAS181 dry powder, formulation F02 in people with Parainfluenza, run by Ansun Biopharma, Inc. at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Stability (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.