Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

NCT02074995 | Terminated Phase 2 Results DMC

• 1 other identifier: CBVS857X2201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks

Conditions

Hypercatabolic Status Related to Severe Burn

Keywords

Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability

  Number of patients with adverse events as a measure of safety and tolerability

  Over 1 year

• Efficacy Measure by Change in Lean Body Mass (LBM)

  Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.

  Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106

Secondary Outcomes (10)

• Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration

  Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

• Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration

  Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

• Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration

  Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

• Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity

  Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105

• Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life

  Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105

Study Arms (3)

BVS857 Grp 1A open label

EXPERIMENTAL

0.03 mg/kg of BVS857intravenously in open label manner

Biological: BVS857

BVS857 Group 1B/1C, 2, 3, 4 Double Blind

EXPERIMENTAL

Biological: BVS857

Placebo Group 1B/1C, 2, 3, 4

PLACEBO COMPARATOR

Other: placebo

Interventions

BVS857 BIOLOGICAL

Group 1A\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.

BVS857 Group 1B/1C, 2, 3, 4 Double Blind; BVS857 Grp 1A open label

placebo OTHER

Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.

Placebo Group 1B/1C, 2, 3, 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
• Dosing must occur within 8-12 days post-burn
• Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study

You may not qualify if:

• Spinal cord injury
• Hypoxic brain injury (Glasgow Coma Scale (GCS) \<8) at screening
• True conductive electric burn with suspected neurologic injury
• Uncontrolled diabetes with HbA1c \> 10% at screening, or known history of hypoglycemia,
• History of or active peripheral neuropathy or seizure disorder
• Systemic corticosteroids : \> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Burns; Cachexia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Limitations and Caveats

Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-03

Locations

US (1)