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Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients (RBV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00993122
First received: October 8, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

The results of antiviral therapy in patients with recurrent hepatitis C after liver transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to be crucial to optimize viral treatment. The aim of this multicenter controlled study is to examine the effect of Ribavirin pre-treatment preceding the combination therapy with peginterferon plus ribavirin on the sustained virological response.


Condition Intervention Phase
Hepatitis C
Drug: ribavirin pre-treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Multicenter Controlled Study of Ribavirin Pre-treatment (8 Weeks) Followed by Standard Therapy With Ribavirin and Pegylated Interferon (48 Weeks) in Transplanted Patients With Recurrence of Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • HCV-RNA level, Transaminases level [ Time Frame: 4°,12°,24°,36°48° week and six months after therapy conclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver biopsy and Transient elastography at baseline and after six month since therapy conclusion [ Time Frame: 0°, 72° week ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ribavirin pre-treatment
patient will receive ribavirin in monotherapy for 8 weeks before the combined 48 weeks antiviral therapy
Drug: ribavirin pre-treatment
patients receive ribavirin (10,4 mg/kg/day) and pegylated interferon alfa-2b (1,5 mcg/kg/week).Pre-treatment arm will receive a 8-week monotherapy treatment with only ribavirin (same dosage) and the controlled arm will receive 48 week of standard combined therapy (ribavirin plus pegylated interferon)
Other Names:
  • ribavirin pre treatment
  • ribavirin priming
  • Recurrence of hepatitis c
  • hepatitis c
  • transplanted patients
  • ribavirin
  • HCV
Active Comparator: combined stardard therapy
patients will receive the standard combined therapy with ribavirin and pegylated interferon for 48 weeks
Drug: ribavirin pre-treatment
patients receive ribavirin (10,4 mg/kg/day) and pegylated interferon alfa-2b (1,5 mcg/kg/week).Pre-treatment arm will receive a 8-week monotherapy treatment with only ribavirin (same dosage) and the controlled arm will receive 48 week of standard combined therapy (ribavirin plus pegylated interferon)
Other Names:
  • ribavirin pre treatment
  • ribavirin priming
  • Recurrence of hepatitis c
  • hepatitis c
  • transplanted patients
  • ribavirin
  • HCV

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Liver transplantation from > 6 months
  2. Positive HCV-RNA viremia
  3. Elevated transaminase levels (greater than 1,2 normal values) in at least two consecutive determinations during the last month
  4. Histology pattern showing hepatitis C recurrence

Exclusion Criteria:

  1. Multiple organ transplantation
  2. Histology showing evidence of hepatic allograft rejection > 3/9 RAI score
  3. Concomitant active biliary disease
  4. Concomitant HBV infection
  5. Normal transaminases levels
  6. Less than 1500 neutrophiles in more than one blood test
  7. Less than 50000 platelets in more than one blood test
  8. Hemoglobin < 9 g/ dL
  9. Creatinine clearance < 35 ml/min
  10. Positive antibodies > 1:80
  11. Auto-immune thyroid pathology
  12. Severe psychiatric disease
  13. Diagnosis of ischemic cardiopathy in the last 12 months
  14. Active alcohol abuse
  15. Low compliance to other medical treatments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993122

Contacts
Contact: manuela merli, professor +39 06 49972002 manuela.merli@uniroma1.it

Locations
Italy
Sapienza University of Rome Recruiting
Rome, Italy, 00100
Contact: manuela merli    +39 06 49972002    manuela.merli@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

Publications:

Responsible Party: manuela merli, sapienza university of rome
ClinicalTrials.gov Identifier: NCT00993122     History of Changes
Other Study ID Numbers: Ribavirin Pre-treatment, Ribavirin Pre-treatment
Study First Received: October 8, 2009
Last Updated: October 13, 2009
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Roma La Sapienza:
pre treatment
therapy compliance
SVR
sustained virological response
TH1 TH2 ratio

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014