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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02234791
Other study ID # BTK-20140828
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 29, 2014
Last updated September 4, 2014
Start date September 2014

Study information

Verified date September 2014
Source Shanghai Children's Medical Center
Contact xiafang chen
Phone 38626161
Email chxf_1984@hotmail.com
Is FDA regulated No
Health authority China: Science and Technology Commission of Shanghai Municipality
Study type Observational [Patient Registry]

Clinical Trial Summary

X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral B cells and a profound deficiency of all immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk) are responsible for most of the gammaglobulinemia.

We tend to investigate the gene mutation and clinical features of Chinese X-linked agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk gene mutations and severity of clinical presentation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Male
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of XLA A.male patients with less than 2% CD19-positive B cells; B.recurrent bacterial infection; C.decreased or absent immunoglobulins in serum

Exclusion Criteria for all groups:

- Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for XLA

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Shanghai Children'S Medical Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary times of pneumonia 2 years Yes