A Phase 3 interventional study of Pioglitazone and Placebo in Chronic Hepatitis C and Insulin Resistance, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 3, Interventional, and Treatment
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.
In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Pioglitazone, 16 weeks before and during antiviral combination therapy
Drug: Pioglitazone
Pioglitazone placebo, 16 weeks before and during antiviral combination therapy
Drug: Placebo
Pioglitazone, 45 mg QD (30 mg QD the first month)
Placebo 45 mg QD (30 mg QD the first month)
Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone.
Time frame: W16
Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis
Time frame: EVR at W16 and W28 SVR at W88
This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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French National Agency for Research on AIDS and Viral Hepatitis