Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

Novartis Pharmaceuticals

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Conditions

Mechanical Ventilation

Interventions

BYM338DRUG

BYM338

PlaceboDRUG

Placebo

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in thigh muscle thickness

Time frame: After 14 days

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

Data from ClinicalTrials.gov

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