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Trial record 62 of 113 for:    centurion

Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

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ClinicalTrials.gov Identifier: NCT03040141
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Visterra, Inc.

Brief Summary:
This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

Condition or disease Intervention/treatment Phase
Influenza A Drug: Low dose of VIS410 in addition to oseltamivir Drug: High dose of VIS410 in addition to oseltamivir Drug: Placebo in addition to oseltamivir Phase 2

Detailed Description:
This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support. Subjects will be followed for 56 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: VIS410 low dose
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
Drug: Low dose of VIS410 in addition to oseltamivir
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir

Experimental: VIS410 high dose
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
Drug: High dose of VIS410 in addition to oseltamivir
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir

Placebo Comparator: Placebo
Single intravenous infusion of placebo in addition to oseltamivir
Drug: Placebo in addition to oseltamivir
Single intravenous infusion of placebo in addition to oseltamivir




Primary Outcome Measures :
  1. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical outcome as assessed by comparison of clinical status ordinal Day 7 scores between treatment groups, and between all VIS410 recipients vs placebo. [ Time Frame: 14 days ]
    Clinical status is measured daily for 14 days using a seven-level ordinal scale, subject status will be classified by the worst clinical outcome for which they qualify

  2. Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized subjects with influenza A infection [ Time Frame: 56 days ]
    The proportion of subjects with AEs and SAEs following administration of VIS410


Secondary Outcome Measures :
  1. Time to cessation of O2 support compared to oseltamivir alone among patients requiring supplemental oxygen therapy at the time of enrollment with baseline room air oxygen saturation of ≤92%. [ Time Frame: 56 days ]
    Time to cessation of O2 support resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of >92% on room air that are at least 8 hours apart.

  2. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on viral titer in upper respiratory samples [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load from nasopharyngeal swabs

  3. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on viral titer in upper respiratory samples [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in time to resolution of viral load from nasopharyngeal swabs

  4. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on time to clinical response [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in time to clinical response defined as resolution of at least 4 of 5 vital signs

  5. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on time to cessation of ventilator support [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in total number of days on ventilation

  6. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on time to resumption of normal activities [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in the number of days to resumption of normal activities

  7. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on all-cause and attributable 28- and 56- day mortality [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in all-cause and attributable mortality rates at Day 28 and 56

  8. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on time to alleviation of signs and symptoms of influenza as assessed by the FluPro Questionnaire at baseline and post-dose Kaplan Meier Analysis [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in the incidence, severity, and duration of signs and symptoms of influenza-like illness as assessed by the FluPRO Questionnaire

  9. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on the proportion of subjects with new documented bacterial pneumonia/superinfection [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in the percentage of subjects with new bacterial pneumonia/superinfection

  10. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on the proportion of subjects with influenza-related complications [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in the percentage of subjects with influenza-related complications

  11. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on the immunogenicity of VIS410 [ Time Frame: 56 days ]
    The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in the titer of anti-VIS410 antibody positive samples

  12. Evaluate the effect of 2 dose levels of VIS410 + oseltamivir vs oseltamivir alone on the emergence of resistance to VIS410 and oseltamivir [ Time Frame: 56 days ]
    Genotypic and/or phenotypic assessments to determine the emergence of VIS410 and oseltamivir-resistant viruses

  13. Pharmacokinetics of VIS410 in Serum [ Time Frame: 56 days ]
    Assess blood/serum samples to determine concentration of VIS410



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥ 18 years.
  • Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test, including PCR, FIA, or ELISA
  • Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.
  • Requirement for oxygen support including any positive pressure ventilation
  • Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.
  • Women should fulfill one of the following criteria:

    • Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history
    • Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
    • Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion.
  • Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method from screening until 60 days post VIS410/placebo infusion.
  • Subject, or a legally acceptable representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies)
  • Subjects who have received VIS410 in the past
  • History of receiving monoclonal antibody products (including VIS410) within 3 months prior to VIS410/placebo dosing or planned administration during the study period
  • Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing
  • Subjects with known co-infection with influenza B or other viral respiratory infections (e.g., respiratory syncytial virus, parainfluenza viruses, respiratory adenoviruses)
  • Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy
  • Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization
  • Subjects with end stage renal disease who are not undergoing hemodialysis
  • Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter
  • Hospitalization for > 48 hours prior to randomization
  • High probability of mortality within 48 hours of randomization as determined by the Investigator
  • Subjects weighing less than 45 kg
  • Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
  • Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator

Information from the National Library of Medicine

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): NCT03040141


Contacts
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Contact: Visterra 617-498-1070 VIS410-203@visterrainc.com

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Sponsors and Collaborators
Visterra, Inc.

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Responsible Party: Visterra, Inc.
ClinicalTrials.gov Identifier: NCT03040141     History of Changes
Other Study ID Numbers: VIS410-203
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action