Mechanical VentilationPhase 2NCT01868685
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
A Phase 2 study testing BYM338 in people with Mechanical Ventilation, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- BYM338
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for >24 hours.
- Expected to survive at least 14 days.
- Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).
Who cannot join
- Patients deemed to be terminal wean patients.
- Patients who have progressive neuromuscular degenerative disorders.
- Patients who are comatose.
- Evidence of unstable medical status.
About this study
Official title: An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
- Conditions
- Mechanical Ventilation
- Being tested
- BYM338, Placebo
- Keywords
- Muscle, anabolism, cachexia, respiratory failure, diaphragm
- Medical subject headings
- Cachexia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYM338Drug
BYM338
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BYM338 | Experimental | Not described Receives: Drug: BYM338 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thigh muscle thickness
Measured: After 14 days
Secondary outcomes (2)
Number of patients with adverse events as a measure of safety and tolerability
Measured: After 12 weeks
Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 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
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868685
- Sponsor's protocol ID
- CBYM338X2207
- Status last verified
- Jan 2015
- First submitted
- 12 Apr 2013
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01868685
- Acronym / sponsor ID
- CBYM338X2207
- Conditions
- Mechanical Ventilation
- Keywords
- Muscle, anabolism, cachexia, respiratory failure, diaphragm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 4 Jun 2013 (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 purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| BYM338 | Experimental | Drug: BYM338 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for >24 hours.
- Expected to survive at least 14 days.
- Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).
Key exclusion criteria (4 listed)
- Patients deemed to be terminal wean patients.
- Patients who have progressive neuromuscular degenerative disorders.
- Patients who are comatose.
- Evidence of unstable medical status.
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 |
|---|---|---|
| BYM338BYM338 | Drug | BYM338 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in thigh muscle thickness
Time frame: After 14 days
2 secondary outcomes
Number of patients with adverse events as a measure of safety and tolerability
Time frame: After 12 weeks
Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients
Time frame: After 12 weeks
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 7 Jan 2015.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BYM338 in people with Mechanical Ventilation, run by Novartis Pharmaceuticals.
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 3 inclusion and 4 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 7 Jan 2015. 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. 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 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?
Change in thigh muscle thickness (time frame: After 14 days). 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 7 Jan 2015.