Hemophagocytic Lymphohistiocytosis (HLH)NCT07909005
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
An observational study of Hemophagocytic Lymphohistiocytosis (HLH) and Macrophage Activation Syndrome (MAS), run by Swedish Orphan Biovitrum at 18 sites in United States.
Trial summary
This study aims to evaluate safety information in patients with HLH/MAS in Still's disease exposed to Gamifant. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS), Still Disease
- What is being tested?
- Local laboratory testing and Local Lab Tests
- How many people
- 70 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2026to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of participating sites who meet the protocol eligibility criteria.
Who may be able to join
- Has received at least 1 dose of Gamifant 0-7 days prior to ICF date or is prescribed to initiate Gamifant.
- Aged ≤80 years at index Gamifant administration.
- Diagnosis of secondary HLH/MAS according to the treating physician.
- Diagnosis or suspicion of Still's disease (sJIA or AOSD) according to the treating physician.
- Patients who have shown inadequate response or intolerance to high-dose glucocorticoids or who have recurrent MAS, according to the treating physician. Recurrent MAS is defined as any MAS episode that has occurred after resolution of the first-ever MAS episode.
- Patient agrees to provide relevant specimen (blood, sputum, and/or urine samples) for laboratory testing as outlined in the study protocol.
- Informed consent must be obtained from the patient or the patient's legally authorized representative.
- For minors capable of providing assent (as determined by local regulations and the Investigator's judgment), informed assent must be obtained in accordance with applicable local regulations. If a minor is unable to provide assent due to age, developmental stage, or medical condition, the reason will be documented.
Who cannot join
- Diagnosis of pHLH or sHLH consequent to proven metabolic, malignancy, or a rheumatic disease other than Still's disease at index date.
- Clinically active Mycobacterium tuberculosis (typical and atypical), Histoplasma capsulatum, or Salmonella infections at the index date based on investigator's assessment.
- Evidence of leishmania infections at the index date based on investigator's assessment.
- Concurrent participation in an interventional clinical trial.
- Severe, uncontrolled concurrent illness at the index date likely to confound outcome assessment with expected survival <28 days based on investigator's assessment.
- Pregnant at the time of study entry
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites
Mott Children's Hospital
Ann Arbor, Michigan, 48109
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30329
Children's of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Atrium Health Levine Childrens Cancer and Blood Disorders a Facility of Carolinas Medical Center
Charlotte, North Carolina, 28203
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Childrens Health Specialty Center Dallas
Dallas, Texas, 75207
Texas Children's Hospital
Houston, Texas, 77030
Childrens Hospital Los Angeles - RHU
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33136
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
Morgan Stanley Children's Hospital
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Seattle Children's Rheumatology
Seattle, Washington, 98105
John Hopkins all Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Long-term Safety of Gamifant® in Adult and Pediatric Patients With HLH/MAS in Still's Disease With Inadequate Response or Intolerance to Glucocorticoids, or With Recurrent MAS
This study aims to evaluate safety information in patients with HLH/MAS in Still's disease exposed to Gamifant.
Read the detailed description
This is a prospective, low intervention, multicenter safety study to evaluate and characterize the long-term safety of Gamifant, an approved treatment for patients with HLH/MAS in known or suspected Still's disease. Pediatric and adult patients with HLH/MAS in known or suspected Still's disease, including sJIA, with inadequate response or intolerance to glucocorticoids, or with recurrent MAS, and who have either initiated Gamifant within the past 0 to 7 days or are prescribed to initiate Gamifant in accordance with the approved product label, are eligible for inclusion in the study.
- Conditions
- Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS), Still Disease
- Being tested
- Local laboratory testing, Local Lab Tests
- Keywords
- Sobi.Emapalumab-107
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Macrophage Activation Syndrome, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local laboratory testingOther
Protocol-mandated assessments include specified laboratory testing at baseline and during the initial 12 months of follow-up (Week 1, Week 2, Month 1, Month 3, Month 6, Month 12): complete blood counts, differential leukocyte count, serum biochemistry/liver function tests, CMV PCR. CMV serology is only required (per protocol) to be conducted at baseline. No laboratory testing is required per protocol after the 12-month visit.
Local Lab TestsOther
Also called Complete blood counts (hematocrit, hemoglobin, platelet count, red blood cell count, white blood cell count), Differential leukocyte countf (lymphocytes, monocytes, neutrophils), Serum biochemistry/Liver function tests (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, bilirubin [total, direct, and indirect]), Virus PCR: CMV PCR
Protocol-mandated assessments include specified laboratory testing at baseline and during the initial 12 months of follow-up (Week 1, Week 2, Month 1, Month 3, Month 6, Month 12): complete blood counts, differential leukocyte count, serum biochemistry/liver function tests, CMV PCR. CMV serology is only required (per protocol) to be conducted at baseline. No laboratory testing is required per protocol after the 12-month visit.
| Study group | Role | What they receive |
|---|---|---|
| HLH/MAS in Still's disease treated with Gamifant | Patients aged ≤80 years at index Gamifant administration who have received at least 1 dose of Gamifant 0-7 days prior to ICF date or is prescribed to initiate Gamifant for the treatment of HLH/MAS in Still's disease Receives: Other: Local laboratory testing; Other: Local Lab Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: Incidence rate of treatment-emergent mycobacterium tuberculosis
Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant.
Unit of Measure: Number of events per 100-patient year
Measured: Timeframe: up to 12 months
Outcome Measure: Incidence rate of treatment-emergent non-tuberculosis mycobacterium infections
Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant.
Unit of Measure: Unit of Measure: Number of events per 100-patient year
Measured: Timeframe: up to 12 months
Outcome Measure: Incidence rate of treatment-emergent CMV reactivation and/or infection
Description: Occurrence of treatment-emergent CMV disease including reactivation and/or infection. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant.
Unit of Measure: Number of events per 100-patient year
Measured: Timeframe: up to 12 months
Outcome Measure: Incidence rate of serious treatment-emergent infections
Description: Occurrence of serious treatment-emergent infections (including CMV reactivation and/or infection, mycobacterium tuberculosis, and non tuberculosis mycobacterial infections). A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant.
Unit of Measure: Number of events per 100-patient year
Measured: Timeframe: up to 12 months
Secondary outcomes (16)
Outcome Measure: Initial Gamifant dose at index
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: mg/kg
Measured: Timeframe: up to 12 months
Outcome Measure: Cumulative Gamifant dose over the index MAS episode
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: mg/kg
Measured: Timeframe: up to 12 months.
Outcome Measure: Duration of Gamifant treatment over the index MAS episode
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: Days
Measured: Timeframe: up to 12 months
Outcome Measure: Gamifant dosing frequency
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant.
Unit of Measure: Number of injections/week
Measured: Timeframe: up to 12 months
Outcome Measure: Maximum single Gamifant dose received
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant.
Unit of Measure: mg/kg
Measured: Timeframe: up to 12 months
Outcome Measure: Total cumulative Gamifant treatment duration and dose during follow-up.
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of Measure: Months
Measured: Timeframe: up to 12 months
Outcome Measure: Total cumulative Gamifant treatment dose during follow-up.
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant Unit of measure: mg/kg
Measured: Timeframe: Up to 12 months
Outcome Measure: Reason for gamifant treatment discontinuation
Description: To describe treatment patterns with Gamifant in patients with HLH/MAS treated with Gamifant.
Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Outcome Measure: Time to MAS resolution
Description: Time-to-event analyses assessing the time from the index date to Investigator-assessed MAS resolution.
Unit of measure: Days
Measured: Timeframe: Up to 12 months
Outcome Measure: Number of participants with HLH/MAS-related hospitalizations
Description: To describe HLH/MAS-related HCRU during treatment with Gamifant. Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Outcome Measure: Duration of intensive care unit (ICU) care
Description: To describe HLH/MAS-related HCRU during treatment with Gamifant Unit of measure: Days
Measured: Timeframe: Up to 12 months
Outcome Measure: Duration of hospitalization/length of stay (LoS)
Description: To describe HLH/MAS-related HCRU during treatment with Gamifant. Unit of measure: Days
Measured: Timeframe: Up to 12 months
Outcome Measure: Number of participants with emergency department visits
Description: To describe HLH/MAS-related HCRU during treatment with Gamifant Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Outcome Measure: Number of participants with Prior HLH/MAS-related medications
Description: Prior medications are those medications that were started and stopped prior to Gamifant initiation.
Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Outcome Measure: Number of participants with Concomitant HLH/MAS-related medications
Description: Concomitant medications are medications that were started prior to or at Gamifant initiation and are ongoing at Gamifant initiation.
Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Outcome Measure: Number of participants with initiation of preemptive antiviral therapy
Description: Concomitant medications are medications that were started prior to or at Gamifant initiation and are ongoing at Gamifant initiation.
Unit of measure: Participants
Measured: Timeframe: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic Lymphohistiocytosis (HLH)Studies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew Ramsey, MD MPH. Study physician, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909005
- Sponsor's protocol ID
- Sobi.Emapalumab-107
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety of Gamifant® in Adult and Pediatric Patients With HLH/MAS in Still's Disease With Inadequate Response or Intolerance to Glucocorticoids, or With Recurrent MAS
- ClinicalTrials.gov ID
- NCT07909005
- Acronym / sponsor ID
- Sobi.Emapalumab-107
- Conditions
- Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS), Still Disease
- Keywords
- Sobi.Emapalumab-107
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- 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 study aims to evaluate safety information in patients with HLH/MAS in Still's disease exposed to Gamifant.
Detailed description
This is a prospective, low intervention, multicenter safety study to evaluate and characterize the long-term safety of Gamifant, an approved treatment for patients with HLH/MAS in known or suspected Still's disease. Pediatric and adult patients with HLH/MAS in known or suspected Still's disease, including sJIA, with inadequate response or intolerance to glucocorticoids, or with recurrent MAS, and who have either initiated Gamifant within the past 0 to 7 days or are prescribed to initiate Gamifant in accordance with the approved product label, are eligible for inclusion in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLH/MAS in Still's disease treated with Gamifant | – | Other: Local laboratory testing, Other: Local Lab TestsPatients aged ≤80 years at index Gamifant administration who have received at least 1 dose of Gamifant 0-7 days prior to ICF date or is prescribed to initiate Gamifant for the treatment of HLH/MAS in Still's disease |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of participating sites who meet the protocol eligibility criteria.
Key inclusion criteria (8 listed)
- Has received at least 1 dose of Gamifant 0-7 days prior to ICF date or is prescribed to initiate Gamifant.
- Aged ≤80 years at index Gamifant administration.
- Diagnosis of secondary HLH/MAS according to the treating physician.
- Diagnosis or suspicion of Still's disease (sJIA or AOSD) according to the treating physician.
- Patients who have shown inadequate response or intolerance to high-dose glucocorticoids or who have recurrent MAS, according to the treating physician. Recurrent MAS is defined as any MAS episode that has occurred after resolution of the first-ever MAS episode.
Key exclusion criteria (6 listed)
- Diagnosis of pHLH or sHLH consequent to proven metabolic, malignancy, or a rheumatic disease other than Still's disease at index date.
- Clinically active Mycobacterium tuberculosis (typical and atypical), Histoplasma capsulatum, or Salmonella infections at the index date based on investigator's assessment.
- Evidence of leishmania infections at the index date based on investigator's assessment.
- Concurrent participation in an interventional clinical trial.
- Severe, uncontrolled concurrent illness at the index date likely to confound outcome assessment with expected survival <28 days based on investigator's assessment.
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 |
|---|---|---|
| Local laboratory testingProtocol-mandated assessments include specified laboratory testing at baseline and during the initial 12 months of follow-up (Week 1, Week 2, Month 1, Month 3, Month 6, Month 12): complete blood counts, differential leukocyte count, serum biochemistry/liver function tests, CMV PCR. CMV serology is only required (per protocol) to be conducted at baseline. No laboratory testing is required per protocol after the 12-month visit. | Other | HLH/MAS in Still's disease treated with Gamifant |
| Local Lab TestsAlso: Complete blood counts (hematocrit, hemoglobin, platelet count, red blood cell count, white blood cell count), Differential leukocyte countf (lymphocytes, monocytes, neutrophils), Serum biochemistry/Liver function tests (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, bilirubin [total, direct, and indirect]), Virus PCR: CMV PCRProtocol-mandated assessments include specified laboratory testing at baseline and during the initial 12 months of follow-up (Week 1, Week 2, Month 1, Month 3, Month 6, Month 12): complete blood counts, differential leukocyte count, serum biochemistry/liver function tests, CMV PCR. CMV serology is only required (per protocol) to be conducted at baseline. No laboratory testing is required per protocol after the 12-month visit. | Other | HLH/MAS in Still's disease treated with Gamifant |
Primary outcome
Outcome Measure: Incidence rate of treatment-emergent mycobacterium tuberculosis
Time frame: Timeframe: up to 12 months
Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year
Outcome Measure: Incidence rate of treatment-emergent non-tuberculosis mycobacterium infections
Time frame: Timeframe: up to 12 months
Description: Occurrence of treatment-emergent mycobacterium tuberculosis and non-tuberculosis mycobacterium. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Unit of Measure: Number of events per 100-patient year
Outcome Measure: Incidence rate of treatment-emergent CMV reactivation and/or infection
Time frame: Timeframe: up to 12 months
Description: Occurrence of treatment-emergent CMV disease including reactivation and/or infection. A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year
Outcome Measure: Incidence rate of serious treatment-emergent infections
Time frame: Timeframe: up to 12 months
Description: Occurrence of serious treatment-emergent infections (including CMV reactivation and/or infection, mycobacterium tuberculosis, and non tuberculosis mycobacterial infections). A TEAE is defined as any AE that occurs from the administration of the index dose of Gamifant until the initial 12 months of follow-up, regardless of relationship to Gamifant. Unit of Measure: Number of events per 100-patient year
16 secondary outcomes
Outcome Measure: Initial Gamifant dose at index
Time frame: Timeframe: up to 12 months
Outcome Measure: Cumulative Gamifant dose over the index MAS episode
Time frame: Timeframe: up to 12 months.
Outcome Measure: Duration of Gamifant treatment over the index MAS episode
Time frame: Timeframe: up to 12 months
Outcome Measure: Gamifant dosing frequency
Time frame: Timeframe: up to 12 months
Outcome Measure: Maximum single Gamifant dose received
Time frame: Timeframe: up to 12 months
Outcome Measure: Total cumulative Gamifant treatment duration and dose during follow-up.
Time frame: Timeframe: up to 12 months
Outcome Measure: Total cumulative Gamifant treatment dose during follow-up.
Time frame: Timeframe: Up to 12 months
Outcome Measure: Reason for gamifant treatment discontinuation
Time frame: Timeframe: Up to 12 months
Outcome Measure: Time to MAS resolution
Time frame: Timeframe: Up to 12 months
Outcome Measure: Number of participants with HLH/MAS-related hospitalizations
Time frame: Timeframe: Up to 12 months
Outcome Measure: Duration of intensive care unit (ICU) care
Time frame: Timeframe: Up to 12 months
Outcome Measure: Duration of hospitalization/length of stay (LoS)
Time frame: Timeframe: Up to 12 months
Outcome Measure: Number of participants with emergency department visits
Time frame: Timeframe: Up to 12 months
Outcome Measure: Number of participants with Prior HLH/MAS-related medications
Time frame: Timeframe: Up to 12 months
Outcome Measure: Number of participants with Concomitant HLH/MAS-related medications
Time frame: Timeframe: Up to 12 months
Outcome Measure: Number of participants with initiation of preemptive antiviral therapy
Time frame: Timeframe: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Andrew Ramsey, MD MPH. Study physician study director
Swedish Orphan Biovitrum
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytosis (HLH) and Macrophage Activation Syndrome (MAS), run by Swedish Orphan Biovitrum at 18 sites 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 8 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Outcome Measure: Incidence rate of treatment-emergent mycobacterium tuberculosis (time frame: Timeframe: up to 12 months). The study lists 4 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 2 Nov 2026.