Acute Respiratory FailurePhase 2/3HBP-NeupogenNCT01713309
Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim)
A Phase 2/3 study testing Filgrastim in people with Acute Respiratory Failure and Critically Ill, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Critically Ill
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteFinland
- Study dates
- Jan 1996to Sep 1998
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Admitted to the ICU no longer than 12 hrs before study entry
- Intubated because of ventilation insufficiency no longer than 48 hrs before study entry
- Clinically expected stay in the ICU > 48 hrs
- Informed consent
Who cannot join
- Pregnant or nursing
- Total leukocyte count of > 50,000/mm3
- Administration of filgrastim, sargramostim, or other biological response modifiers within 7 days before study entry
- Known hypersensitivity or allergic reaction to Escherichia coli-derived products
- Participation in another drug study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.
- Conditions
- Acute Respiratory Failure, Critically Ill
- Being tested
- Filgrastim
- Keywords
- Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Neupogen
Filgrastim 300 ug daily for 7 days, subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Active comparator | Filgrastim 300 microgr/day subcutaneously for 7 days Receives: Drug: Filgrastim |
| NaCl 0.9% | Placebo comparator | Corresponding placebo once daily, subcutaneously for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.
Measured: up to 28 days
Secondary outcomes (1)
follow up measures
frequency of nosocomial infections, length of mechanical ventilatory support, length of stay in the ICU, 28-day mortality rate, 90-day mortality rate, and laboratory values for neutrophil count
Measured: Up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startJan 1996
- Primary completionJun 1998
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Kirsi-Maija Kaukonen, Helsinki University Central Hospital
- Investigators
- Ville Pettila, MD, PhD, Study director, Helsinki University Central HospitalKirsi-Maija Kaukonen, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713309
- Sponsor's protocol ID
- HBP01
- Acronym
- HBP-Neupogen
- Status last verified
- Oct 2012
- First submitted
- 14 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011.
PubMed 11098963Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2.
PubMed 15883741Kaukonen KM, Herwald H, Lindbom L, Pettila V. Heparin binding protein in patients with acute respiratory failure treated with granulocyte colony-stimulating factor (filgrastim)--a prospective, placebo-controlled, double-blind study. BMC Infect Dis. 2013 Jan 30;13:51. doi: 10.1186/1471-2334-13-51.
PubMed 23363492
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With Granulocyte Colony-stimulating Factor (Filgrastim)
- ClinicalTrials.gov ID
- NCT01713309
- Acronym / sponsor ID
- HBP-Neupogen / HBP01
- Conditions
- Acute Respiratory Failure, Critically Ill
- Keywords
- Filgrastim, G-CSF, Heparin-binding protein, critically ill, acute respiratory failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Jan 1996
- Primary completion
- Jun 1998 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Active comparator | Drug: FilgrastimFilgrastim 300 microgr/day subcutaneously for 7 days |
| NaCl 0.9% | Placebo comparator | –Corresponding placebo once daily, subcutaneously for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Admitted to the ICU no longer than 12 hrs before study entry
- Intubated because of ventilation insufficiency no longer than 48 hrs before study entry
- Clinically expected stay in the ICU > 48 hrs
- Informed consent
Key exclusion criteria (5 listed)
- Pregnant or nursing
- Total leukocyte count of > 50,000/mm3
- Administration of filgrastim, sargramostim, or other biological response modifiers within 7 days before study entry
- Known hypersensitivity or allergic reaction to Escherichia coli-derived products
- Participation in another drug study
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 |
|---|---|---|
| FilgrastimAlso: NeupogenFilgrastim 300 ug daily for 7 days, subcutaneously. | Drug | Filgrastim |
Primary outcome
Number of adverse events
Time frame: up to 28 days
the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7.
1 secondary outcome
follow up measures
Time frame: Up to day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Results publication: PubMed 11098963Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011.
- Results publication: PubMed 15883741Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2.
- Derived from this study: PubMed 23363492Kaukonen KM, Herwald H, Lindbom L, Pettila V. Heparin binding protein in patients with acute respiratory failure treated with granulocyte colony-stimulating factor (filgrastim)--a prospective, placebo-controlled, double-blind study. BMC Infect Dis. 2013 Jan 30;13:51. doi: 10.1186/1471-2334-13-51.
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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.
Ville Pettila, MD, PhD study director
Helsinki University Central Hospital
Kirsi-Maija Kaukonen, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Filgrastim in people with Acute Respiratory Failure and Critically Ill, run by Helsinki University Central Hospital at 1 site in Finland.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Oct 2012. 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 Finland. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 adverse events (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713309, which also lists 3 linked publications.
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 29 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.