Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

Phase 2

Withdrawn

• Conditions: Mechanical Ventilation
• Interventions: Drug: Placebo; Drug: BYM338

• Registration Number: NCT01868685
• Lead Sponsor: Novartis Pharmaceuticals

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 available

Study Timeline

• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Study Start: 2014-04
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BYM338	BYM338	-

Primary Outcome Measures

Name	Time	Method
Change in thigh muscle thickness	After 14 days

Secondary Outcome Measures

Name	Time	Method
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