Study of Muscle Effects of BYM338 in Mechanically Ventila... | NCT01868685

Studies
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

NCT01868685

Sponsor

Novartis Pharmaceuticals

Status

Withdrawn

Last Update Posted

Jan 7, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Mechanical Ventilation

Interventions

BYM338
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Apr 12, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

Jun 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2015

Last Update Posted Date

Jan 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
BYM338	Experimental		Drug: BYM338

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BYM338	Drug	BYM338	BYM338
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in thigh muscle thickness		After 14 days

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events as a measure of safety and tolerability		After 12 weeks
Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients		After 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

Patients deemed to be terminal wean patients.
Patients who have progressive neuromuscular degenerative disorders.
Patients who are comatose.
Evidence of unstable medical status.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002100	Cachexia
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000596367	bimagrumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided