Influenza - Type A StrainsPhase 2NCT03028909
Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.
A Phase 2 study testing Oseltamivir and MEDI8852 in people with Influenza - Type A Strains, run by MedImmune LLC.
Trial summary
The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Influenza - Type A Strains
- What is being tested?
- Oseltamivir and MEDI8852
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2017to 26 Jul 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of screening. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States, Data Privacy Directive in Europe) obtained from the subject/legal representative prior to performing any protocol related procedures, including screening evaluations.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must have evidence of not being pregnant upon enrollment and have a negative pregnancy test prior to administration of investigational product. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to participate in the study through Day 60.
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results.
- Concurrent enrollment in another clinical study involving an investigational treatment. -Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A.
- Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. -Receipt of any investigational antiviral medications within 30 days prior to study drug dosing.
- Previous receipt of an influenza mAb within past 100 days.
- Pregnant or nursing female.
- History of allergic disease or reactions likely to be exacerbated by any components of the study drugs (MEDI8852 or oseltamivir).
- Diagnosis of influenza B infection within 14 days prior to randomization.
- Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
About this study
Official title: A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains
The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.
Read the detailed description
The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.
- Conditions
- Influenza - Type A Strains
- Being tested
- Oseltamivir, MEDI8852, Placebo
- Keywords
- Influenza A, MEDI8852
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Tamiflu
Standard of care for influenza caused by Type A strains
MEDI8852Drug
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
PlaceboDrug
Salt-water solution containing no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir + low dose MEDI8852 | Experimental | Low Dose of MEDI8852 + Oseltamivir will be studied Receives: Drug: Oseltamivir; Drug: MEDI8852 |
| Oseltamivir + high dose MEDI8852 | Experimental | High dose of MEDI8852 + Oseltamivir will be studied. Receives: Drug: Oseltamivir; Drug: MEDI8852 |
| Oseltamivir + Placebo | Active comparator | Oseltamivir in conjunction with placebo will be studied. Receives: Drug: Oseltamivir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy as defined as time to normalization of respiratory function.
To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function.
Measured: Through Day 14
The occurence of Adverse Events
Occurrence of adverse events.
Measured: Through Day 28
The occurence of Serious Adverse Events
Occurrence of serious adverse events.
Measured: Through Study Day 60
The occurence of Adverse Events of Special Interest (AESIs)
Occurrence of Adverse Events of Special Interest.
Measured: Through Day 60
Secondary outcomes (12)
Assessment of the effect of MEDI8852 in reducing severity of clinical status.
Evaluation of the effect of MEDI8852 in reducing severity of clinical status defined by death, ICU, non-ICU hospitalization, but requiring supplemental oxygen, non-ICU hospitalization and not requiring supplemental oxygen, not hospitalized, but unable to resume normal activities, fully resumed normal activities
Measured: Through Day 7
Evaluation of time to hospital discharge.
Evaluation of time to hospital discharge.
Measured: Through Day 60
Quantitation of influenza viral shedding by qRT-PCR.
Evaluation of the effect of MEDI8852 in reducing the duration and quantity of viral shedding measured by qRT-PCR over time.
Measured: Through Day 60
Evaluation of serum concentrations and PK of MEDI8852.
To evaluate serum concentration of MEDI8852 through Day 60.
Measured: Through Day 60
Evaluation of serum ADA responses in serum through Day 60.
To evaluate the ADA response through Day 60.
Measured: Through Day 60
Evaluation of time to ICU discharge.
Evaluation of time to ICU discharge.
Measured: Through Day 60
Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.
To evaluate time to clinical resolution of vital sign abnormalities.
Measured: Through Day 14
Evaluation of Change in NEWS from baseline through Day 14.
To evaluate the effect of MEDI8852 in reducing NEWS.
Measured: Through Day 14
Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.
To evaluate duration of mechanical ventilation.
Measured: Through Day 60
Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.
To evaluate the rate of ICU admission from the general ward.
Measured: Through Day 60
Evaluation to determine the effect of MEDI8852 on all-cause mortality
To evaluate All-cause mortality.
Measured: Through Day 60
Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.
To evaluate the rate of all-cause re-admission during the study.
Measured: Through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start24 Jul 2017 (estimated)
- Primary completion26 Jul 2019 (estimated)
- Study completion26 Jul 2019 (estimated)
Why it stopped: Study is withdrawn due to company decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza - Type A StrainsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028909
- Sponsor's protocol ID
- D6000C00003
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains
- ClinicalTrials.gov ID
- NCT03028909
- Acronym / sponsor ID
- D6000C00003
- Conditions
- Influenza - Type A Strains
- Keywords
- Influenza A, MEDI8852
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is withdrawn due to company decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (estimated)
- Primary completion
- 26 Jul 2019 (estimated)
- Study completion
- 26 Jul 2019 (estimated)
- First posted
- 23 Jan 2017 (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.
The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.
Detailed description
The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir + low dose MEDI8852 | Experimental | Drug: Oseltamivir, Drug: MEDI8852Low Dose of MEDI8852 + Oseltamivir will be studied |
| Oseltamivir + high dose MEDI8852 | Experimental | Drug: Oseltamivir, Drug: MEDI8852High dose of MEDI8852 + Oseltamivir will be studied. |
| Oseltamivir + Placebo | Active comparator | Drug: Oseltamivir, Drug: PlaceboOseltamivir in conjunction with placebo will be studied. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older at the time of screening. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States, Data Privacy Directive in Europe) obtained from the subject/legal representative prior to performing any protocol related procedures, including screening evaluations.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must have evidence of not being pregnant upon enrollment and have a negative pregnancy test prior to administration of investigational product. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to participate in the study through Day 60.
Key exclusion criteria (8 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results.
- Concurrent enrollment in another clinical study involving an investigational treatment. -Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A.
- Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. -Receipt of any investigational antiviral medications within 30 days prior to study drug dosing.
- Previous receipt of an influenza mAb within past 100 days.
- Pregnant or nursing female.
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 |
|---|---|---|
| OseltamivirAlso: TamifluStandard of care for influenza caused by Type A strains | Drug | Oseltamivir + Placebo, Oseltamivir + high dose MEDI8852, Oseltamivir + low dose MEDI8852 |
| MEDI8852MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion. | Drug | Oseltamivir + high dose MEDI8852, Oseltamivir + low dose MEDI8852 |
| PlaceboSalt-water solution containing no active ingredients. | Drug | Oseltamivir + Placebo |
Primary outcome
Evaluation of efficacy as defined as time to normalization of respiratory function.
Time frame: Through Day 14
To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function.
The occurence of Adverse Events
Time frame: Through Day 28
Occurrence of adverse events.
The occurence of Serious Adverse Events
Time frame: Through Study Day 60
Occurrence of serious adverse events.
The occurence of Adverse Events of Special Interest (AESIs)
Time frame: Through Day 60
Occurrence of Adverse Events of Special Interest.
12 secondary outcomes
Assessment of the effect of MEDI8852 in reducing severity of clinical status.
Time frame: Through Day 7
Evaluation of time to hospital discharge.
Time frame: Through Day 60
Quantitation of influenza viral shedding by qRT-PCR.
Time frame: Through Day 60
Evaluation of serum concentrations and PK of MEDI8852.
Time frame: Through Day 60
Evaluation of serum ADA responses in serum through Day 60.
Time frame: Through Day 60
Evaluation of time to ICU discharge.
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.
Time frame: Through Day 14
Evaluation of Change in NEWS from baseline through Day 14.
Time frame: Through Day 14
Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.
Time frame: Through Day 60
Evaluation to determine the effect of MEDI8852 on all-cause mortality
Time frame: Through Day 60
Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.
Time frame: Through Day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oseltamivir and MEDI8852 in people with Influenza - Type A Strains, run by MedImmune LLC.
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 2 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: withdrawn, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of efficacy as defined as time to normalization of respiratory function. (time frame: Through Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.