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NOT YET RECRUITING
NCT07909005

Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.

Sponsor: Swedish Orphan Biovitrum

View on ClinicalTrials.gov

Summary

This study aims to evaluate safety information in patients with HLH/MAS in Still's disease exposed to Gamifant.

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

Key Details

Gender

All

Age Range

Any - 80 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2026-12

Completion Date

2030-12

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

OTHER

Local laboratory testing

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.

OTHER

Local Lab Tests

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.

Locations (18)

Children's of Alabama

Birmingham, Alabama, United States

Childrens Hospital Los Angeles - RHU

Los Angeles, California, United States

University of Miami

Miami, Florida, United States

John Hopkins all Children's Hospital

St. Petersburg, Florida, United States

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Morgan Stanley Children's Hospital

New York, New York, United States

Atrium Health Levine Childrens Cancer and Blood Disorders a Facility of Carolinas Medical Center

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Childrens Health Specialty Center Dallas

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Rheumatology

Seattle, Washington, United States