Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01473849
Other study ID # VHENUS
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 30, 2011
Last updated December 19, 2012
Start date May 2010
Est. completion date April 2013

Study information

Verified date December 2012
Source Sociedad Española de Trasplante Hepático
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 179
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA

- Age > 18 years old

Exclusion Criteria:

- Patients co-infected with HBV or HIV

- Patients who show other causes of liver disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Reina Sofía Córdoba
Spain Hospital de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital 12 de Octubre Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Universitario Carlos Haya Málaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Clínica Universitaria de Navarra Pamplona Navarra
Spain Complejo Hospitalario Universitario de Santiago Santiago de Compostela A Coruña
Spain Hospital Virgen del Rocío Sevilla
Spain Hospital Universitario Río Hortega Valladolid
Spain Hospital Clínico Lozano Blesa Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Sociedad Española de Trasplante Hepático Roche Farma, S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of CMV replication over hepatitis C recurrence viral charge of HCV will be assessed 48 weeks after transplantation 48 weeks after transplantation No
Secondary Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation 1 year No
Secondary Effect of CMV recurrence over graft and patient survival 1 year No
Secondary Relationship between viral charge of CMV and HCV during study period 1 year No
See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Recruiting NCT04510246 - Link Hepatitis C Notifications to Treatment in Tasmania N/A
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT01458054 - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults Phase 1
Completed NCT03740230 - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Completed NCT00006301 - Immune Response to Hepatitis C Virus
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Recruiting NCT04405024 - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients N/A
Completed NCT04525690 - Improving Inpatient Screening for Hepatitis C N/A
Completed NCT04033887 - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn NCT04546802 - HepATocellular Cancer Hcv Therapy Study Phase 3
Active, not recruiting NCT02961426 - Strategic Transformation of the Market of HCV Treatments Phase 2/Phase 3
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study N/A
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1