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Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis (RIBACIR)

This study has been terminated.
(Preliminary analysis)
Sponsor:
Information provided by (Responsible Party):
Agustin Albillos, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00840489
First received: February 9, 2009
Last updated: January 30, 2013
Last verified: January 2013

February 9, 2009
January 30, 2013
January 2009
December 2012   (final data collection date for primary outcome measure)
Hepatic disease progression defined by a difference of >2 mmHg in the hepatic venous gradient between the basal values and the end of treatment values in both groups [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00840489 on ClinicalTrials.gov Archive Site
Decrease in the necroinflammatory activity and in the progression of fibrosis. Normalization of ALT levels. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis
Phase II Trial of Long-term Monotherapy With Ribavirin Against Colchicine on Progression of Chronic Hepatitis C With Advanced Fibrosis in Patients With Non-response to Standard Antiviral Therapy

The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Ribavirin
    Ribavirin 1000-1200 mg qd for 24 weeks
    Other Name: Rebetol
  • Drug: Colchicine
    Colchicine 0.5 mg bd for 24 weeks
    Other Name: Colchimax
  • Experimental: Ribavirin
    Ribavirin 1000-1200 mg qd
    Intervention: Drug: Ribavirin
  • Active Comparator: Colchicine
    Colchicine 0.5 mg bd
    Intervention: Drug: Colchicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HCV RNA in serum
  • AST/ALT greater than the upper limit of normal range
  • HVPG >5 mm Hg
  • Non-response or contraindication to a standard course of antiviral therapy

Exclusion Criteria:

  • Active alcoholism
  • HIV infection
  • Serum creatinine >1.2 mg/dl, hemoglobin <11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease
  • Decompensated chronic liver disease
  • Pregnancy
  • Hypersensitivity to the drugs of the study
  • Severe concomitant disease
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00840489
RIBACIR-1
No
Agustin Albillos, Hospital Universitario Ramon y Cajal
Hospital Universitario Ramon y Cajal
Not Provided
Principal Investigator: Agustín Albillos, MD Hospital Universitario Ramón y Cajal
Study Director: José Luis Calleja, MD Hospital Universitario Puerta de Hierro Majadahonda
Study Director: Rafael Bañares, MD Hospital General Universitario Gregorio Marañón
Hospital Universitario Ramon y Cajal
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP