Steroid-refractory Bronchiolitis ObliteransPhase 2IFN_BOSZT_01NCT01639261
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT
A Phase 2 study testing Interferon gamma 1b in people with Steroid-refractory Bronchiolitis Obliterans, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
Improvement of quality of life in patients with BO and establishment of a new third line therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steroid-refractory Bronchiolitis Obliterans
- What is being tested?
- Interferon gamma 1b
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 2014
- Phase
- Phase 2
- 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
- Allogeneic SCT
- Age ≥ 18 years
- BO, firmed by 2 out of 3 examinations:
- Lung function/ BGA
- CT scan in in- and expiration or
- Histological diagnosis
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- Therapy refractory BO, i.e. no improvement during at least three therapies, among:
- Azithromycin + inhaled steroids/ bronchodilators
- Systemic steroids 1 mg/kg BW
- One of the following therapies: MMF, mTOR inhibitors or ECP
- Effective contraception (before, during and for 8 weeks after the treatment)
- Blood count: no severe neutropenia, defined as ANC > 1000/ml, platelets > 50/nl and haemoglobin > 8 g/dl
- Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) lower than 3 x paramount normal range
- Kreatinin lower than 3 x paramount normal range
- Informed consent
Who cannot join
- Age < 18 years
- Pregnant or nursing woman
- No appropriate contraception
- Participation in any other study within 4 weeks before or during the study
- Active acute GvHD of other organs than the lung > grade II or severe active chronic GvHD
- No appropriate antibiotic/ antimycotic therapy in documented infection
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- Severe bone marrow suppression (ANC < 1000/ml) or graft failure
- Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) higher than 3 x paramount normal range
- Kreatinin higher than 3 x paramount normal range
- Participation in another study within 4 weeks before or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Improvement of quality of life in patients with BO and establishment of a new third line therapy
Read the detailed description
Primary Objectives:
Objective improvement of lung function, i.e.:
- Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or
- Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or
- Improvement of obstructive parameters ≥ 20 % or
- Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.
Secondary Objectives
- Morphological improvement of BO/BOOP at CT scan
- Reduction of steroids about at least 20 %
- Being tested
- Interferon gamma 1b
- Keywords
- steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma 1bDrug
Also called Imukin
Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week
What is being measured
The primary outcome is the main question the study is designed to answer.
therapy response
Enhancement of therapy response from 15 % to 50 %
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-refractory Bronchiolitis ObliteransStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- ClinAssess GmbH
- Responsible party
- Principal investigator, Professor Ernst Holler MD, University Hospital Regensburg
- Investigators
- Ernst Holler, Professor MD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639261
- Sponsor's protocol ID
- IFN_BOSZT_01
- Other IDs
- 2010-022467-36
- Acronym
- IFN_BOSZT_01
- Status last verified
- Jul 2012
- First submitted
- 9 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
- ClinicalTrials.gov ID
- NCT01639261
- Acronym / sponsor ID
- IFN_BOSZT_01 / IFN_BOSZT_01
- Keywords
- steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Collaborators
- ClinAssess GmbH
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Jul 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.
Improvement of quality of life in patients with BO and establishment of a new third line therapy
Detailed description
Primary Objectives:
Objective improvement of lung function, i.e.:
- Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or
- Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or
- Improvement of obstructive parameters ≥ 20 % or
- Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.
Secondary Objectives
- Morphological improvement of BO/BOOP at CT scan
- Reduction of steroids about at least 20 %
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Allogeneic SCT
- Age ≥ 18 years
- BO, firmed by 2 out of 3 examinations:
- Therapy refractory BO, i.e. no improvement during at least three therapies, among:
- Effective contraception (before, during and for 8 weeks after the treatment)
Key exclusion criteria (10 listed)
- Age < 18 years
- Pregnant or nursing woman
- No appropriate contraception
- Participation in any other study within 4 weeks before or during the study
- Active acute GvHD of other organs than the lung > grade II or severe active chronic GvHD
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 |
|---|---|---|
| Interferon gamma 1bAlso: ImukinInitial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week | Drug | – |
Primary outcome
therapy response
Time frame: 24 weeks
Enhancement of therapy response from 15 % to 50 %
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
Ernst Holler, Professor MD principal investigator
University Hospital Regensburg
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 Interferon gamma 1b in people with Steroid-refractory Bronchiolitis Obliterans, run by University Hospital Regensburg at 1 site in Germany.
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Jul 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 Germany. 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. 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?
Results are not available in the source record.
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?
therapy response (time frame: 24 weeks). 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 12 Jul 2012.