Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease

Phase 1

Conditions: CVID patients confirmed according to ESID/PAGID criteria or related disorders which fulfill the diagnostic criteria for CVID and interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
MedDRA version: 18.1Level: PTClassification code 10022611Term: Interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1Level: PTClassification code 10021449Term: Immunodeficiency common variableSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-002491-24-DE

Lead Sponsor: niversitätsklinikum Freiburg, vertreten durch den Leitenden Ärztlichen Direktor

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. Diagnosis of CVID according to ESID/PAGID criteria or diagnosis of related disorders which fulfill the diagnostic criteria for CVID
2. Interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
3. Age 18 years and above
4. Signed written informed consent
5. Not responsive to steroid monotherapy for a minimum of three months or intolerance of steroid therapy
6. Need for intervention measured by either reduced oxygen saturation, drop of oxygen saturation under exercise or reduced DLCOcSB
OR
progress of interstitial lung disease measured by progressive changes in the CT scan of the lung

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study
2. Other immunosuppressive therapy including biologicals beyond steroid at screening phase
3. Previous treatment with Abatacept
4. Active Hepatitis B infection or tuberculosis infection
5. Other Uncontrolled infection
6. Lymphoma within the past 5 years
7. Pregnancy indicated by positive urine pregnancy test at screening
8. Breast feeding patients
9. Fertile patients refusing to use safe contraceptive methods during the study
10. Simultaneous participation in other interventional clinical trials