Pharmacokinetics of Mycophenolate Mofetil in de novo lung allograft recipients - CELMACS

• Conditions: Prevention of acute allograft rejections in de novo lung allograft recipients; MedDRA version: 12.0Level: LLTClassification code 10051604Term: Lung transplant rejection

• Registration Number: EUCTR2009-012231-15-DE
• Lead Sponsor: Roche Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patient received a primary single or bilat-eral lung allograft.
2.Primary reason for lung transplantation was cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or alpha-1 antitrypsin deficiency.
3.According to center practice patient re-ceives corticosteroids and cyclosporine as part of the immunosuppressive regime.
4.Patient is 18 years of age or older.
5.Patient is capable of understanding the purposes and risks of the study and is able to reliably report any adverse event.
6.Patient is willing to give written informed consent, written consent for data protec-tion and willingness to participate and to comply with the study.
7.Females of childbearing potential will have a negative pregnancy test at screening.
8.Patient agrees to utilize contraceptive methods throughout the study period, dur-ing treatment with mycophenolate mofetil and for 6 weeks following discontinuation of therapy
9. In general, women of childbearing potential should be using highly effective contraception to participate in clincial studies. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1 % per year) when used consistently and corrrectly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Retransplanted lung allograft recipients or multiple organ transplant recipients.
2.Patient has severe diarrhea or other gas-trointestinal disorder including biliary dis-ease interfering with his / her ability to ab-sorb oral medication. Cystic fibrosis is not an exclusion criterion.
3.Patient received an investigational new drug within the last 30 days.
4.Patient participates simultaneously in an-other clinical trial.
5.Patient participated in this study before.
6.Women lactating, pregnant or of childbear-ing potential not using a reliable contra-ceptive method.
7.Patient is underage or incapable to under-stand the aim, importance and conse-quences of the study and to give legal in-formed consent according to §40 Abs. 4 and §41 Abs. 2 and Abs. 3 AMG.
8.Patient has a history of psychiatric illness or condition such as to interfere with the patient´s ability to understand the require-ments of the study.
9.Patients who possibly are dependent on the sponsor or investigator.
10.Patient has exhibited in the past an allergic or other significant adverse reaction to my-cophenolate mofetil.
11.Patient has liver function test results greater than 3 times the upper limit of nor-mal (ULN).
12.Patient is positive for HIV or Hepatitis C.
13.Patient is positive for HBsAg and/or HBV-DNA. Inclusion of patients positive for anti-HBs and/or anti-HBc but negative for HBsAg and/or HBV-DNA is permitted.
14.Patients with malignancies or history of malignancy.
15.Patient has a current severe illness or any other condition(s) (e.g. psychiatric disor-der) which would make the subject in the opinion of the investigator unsuitable for the study.
16.Patient received prohibited medication as defined in section 4.5

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified