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NCT01791166 Clinical Trial

Immuno-humoral Rejection Markers in Pulmonary Transplant

Lung Transplant Clinical Trial

— RHUM-TP  

Official title:
Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01791166
Other study ID # 2010/49
Secondary ID
Status Completed
Phase N/A
First received February 12, 2013
Last updated September 9, 2016
Start date February 2011
Est. completion date July 2014

Study information
Verified date September 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date July 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Both genders, more than 18 years of age.

- Patients with or without Cystic fibrosis

- Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant

- Patients with no current other disease can affect, in short term, the process or prognosis of the transplant

- Patients had given his agreement to be enrolled in the study

Exclusion Criteria:

- Patient less than 18 year-old

- Patient had previous organ transplant

- Pregnant and/or lactating women

- Female subject in reproductive age does not use effective contraceptive methode

- Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Biological:
• Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

Locations
Country Name City State
France Hôpital FOCH Suresnes Ile de France

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers. 12 months after pulmonary transplant No
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