Hypercatabolic Status Related to Severe BurnPhase 2NCT02074995
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
A Phase 2 study testing BVS857 in people with Hypercatabolic Status Related to Severe Burn, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypercatabolic Status Related to Severe Burn
- What is being tested?
- BVS857
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
About this study
Official title: Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
Read the detailed description
No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)
- Being tested
- BVS857, placebo
- Keywords
- Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing
- Medical subject headings
- Burns, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVS857Biological
Group 1A\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
placeboOther
Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
| Study group | Role | What they receive |
|---|---|---|
| BVS857 Grp 1A open label | Experimental | 0.03 mg/kg of BVS857intravenously in open label manner Receives: Biological: BVS857 |
| BVS857 Group 1B/1C, 2, 3, 4 Double Blind | Experimental | Not described Receives: Biological: BVS857 |
| Placebo Group 1B/1C, 2, 3, 4 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over 1 year
Efficacy Measure by Change in Lean Body Mass (LBM)
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration
Measured: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: The study was prematurely terminated due to recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypercatabolic Status Related to Severe BurnStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074995
- Sponsor's protocol ID
- CBVS857X2201
- Status last verified
- Mar 2016
- First submitted
- 27 Feb 2014
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
- ClinicalTrials.gov ID
- NCT02074995
- Acronym / sponsor ID
- CBVS857X2201
- Keywords
- Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to recruitment issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
Detailed description
No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BVS857 Grp 1A open label | Experimental | Biological: BVS8570.03 mg/kg of BVS857intravenously in open label manner |
| BVS857 Group 1B/1C, 2, 3, 4 Double Blind | Experimental | Biological: BVS857 |
| Placebo Group 1B/1C, 2, 3, 4 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVS857Group 1A\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses. | Biological | BVS857 Group 1B/1C, 2, 3, 4 Double Blind, BVS857 Grp 1A open label |
| placeboGroup 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses. | Other | Placebo Group 1B/1C, 2, 3, 4 |
Primary outcome
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time frame: Over 1 year
Number of patients with adverse events as a measure of safety and tolerability
Efficacy Measure by Change in Lean Body Mass (LBM)
Time frame: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.
10 secondary outcomes
Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration
Time frame: Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BVS857 in people with Hypercatabolic Status Related to Severe Burn, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events as a Measure of Safety and Tolerability (time frame: Over 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.