Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

Mechanical Ventilation Clinical Trial

Official title:

An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01868685
• Other study ID #: CBYM338X2207
• Status: Withdrawn
• Phase: Phase 2
• First received: April 12, 2013
• Last updated: January 6, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Drug:
• BYM338
BYM338
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in thigh muscle thickness		After 14 days	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability		After 12 weeks	Yes
Secondary	Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients		After 12 weeks	No