Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00582738

Purpose

This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant

Condition	Intervention	Phase
Recurrent Hepatitis C	Drug: Everolimus Drug: standard treatment	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Controlled, Open Label, Two Arms, Exploratory Study to Evaluate the Effect of Everolimus on Histologically Assessed Fibrosis Progression (Ishak-Knodell) in Liver Transplant Recipients With Recurrent Hepatitis C Viral Infection as Compared to Standard Treatment.

Further study details as provided by Novartis:

Primary Outcome Measures:

Difference in fibrosis staging scores (measured by the Ishak-knodell staging score) between baseline and 24 months post randomization for each patient [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean fibrosis staging scores measured by the Ishak-knodell staging score and Metavir staging score at 12/24 months and mean change at 12 post randomization Inflammatory Acti-test and fibrosis Fibro-testcomponents of Fibrosure TM and on fibrosi [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
1: Experimental everlimous	Drug: Everolimus Hepatitis C recurrence after orthotopic liver transplantation (OLT)
2: Active Comparator standard treatment	Drug: standard treatment standard treatment

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients 18 - 65 years of age
Recipients of deceased or living donors
Patients who had undergone primary liver transplantation at least 6 months before enrolment
Recurrent Hepatitis C viral infection and histologically confirmed liver fibrosis (stage I-IV in the Ishak-Knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
Patients receiving tacrolimus or cyclosporine micro-emulsion with or without - Mycophenolic acid (MPA), with or without steroids.
Absence of acute rejection episodes within the previous 6 months to the date of enrolment
Patient in whom an allograft biopsy will not be contraindicated
Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
Patients with Hepatocellular carcinoma (HCC) within the University California, San Francisco (UCSF) Criteria and no recurrence for at least 18 months after OLT.

Exclusion Criteria:

Recipients of multiple organ transplants or patients who have undergone retransplantation
Current biliary complications
History of drug or alcohol abuse within 1 year before enrolment
Patients treated with anti-hepatitis C virus treatment at the time of enrollment or within the previous month to the date of enrolment
Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
Patients with Leukocyte count (WBC) < 3000/mm3, platelet count < 75000/mm3 or Hemoglobin (Hb) < 8 g/dl
Patients with proteinuria >1g/24 hours
Patient with a current severe systemic infection

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582738

Contacts

Contact: Novarts Pharmaceuticals

41613241111

Locations

Argentina
Novartis Investigative site	Recruiting
Buenos Aires, Argentina
Contact: Novartis 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001H2301
Study First Received:	December 12, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00582738
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Fibrosis progression
recurrent hepatitis C
viral infection

liver transplant recipients
everolimus
Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Study placed in the following topic categories:

Everolimus
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Fibrosis
Disease Progression
Hepatitis, Viral, Human
Hepatitis C
Recurrence

Additional relevant MeSH terms:

Disease Attributes
RNA Virus Infections
Pathologic Processes
Immunologic Factors
Flaviviridae Infections

Physiological Effects of Drugs
Infection
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009