Therapy of Hepatitis C positive renal transplant patients with Daclatasvir and Sofosbuvir with Focus on efficacy and safety

Conditions: ?Therapy for chronic HCV-infected? renal transplant patients
MedDRA version: 18.0Level: LLTClassification code 10054990Term: Immunodeficiency secondary to organ transplantationSystem Organ Class: 100000004870
MedDRA version: 18.0Level: LLTClassification code 10002724Term: Anti-HCV positiveSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-004551-32-DE

Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. >18 year old renal transplant recipients
2. Renal transplant patients with chronic HCV-infection, Genotyp Ia and Ib with HCV RNA
3. Renal transplant patients with untreated or previously failed treatment of HCV-infection
4. Renal transplant patients with calculated glomerular filtration rate (cGFR) according to the CKD-EPI formula >30ml/min
5. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
6. Women of childbearing potential (WOCBP) should have a negative pregnancy test (serum or urine) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. WOCBP who is either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
2. Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
3. Treatment with any investigational drug within 3 months preceding the study
4. Patient with a history of malignancies in the last 5 years with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
5. Patients with Co-infection with HIV or HBV
6. Patients with evidence of a medical condition associated with chronic decompensated liver disease (Child-Pugh class B or C)
7. Patients who suffered from severe rejection (= Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrolment in this study.