NCT01868685

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

April 12, 2013

Last Update Submit

January 6, 2015

Conditions

Mechanical Ventilation

Keywords

Muscle, anabolism, cachexia, respiratory failure, diaphragm

Outcome Measures

Primary Outcomes (1)

  • Change in thigh muscle thickness

    After 14 days

Secondary Outcomes (2)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

BYM338

EXPERIMENTAL
Drug: BYM338

Interventions

BYM338DRUG

BYM338

BYM338
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CachexiaRespiratory Insufficiency

Interventions

bimagrumab

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

June 4, 2013

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 7, 2015

Record last verified: 2015-01