Status:
COMPLETED
Retreatment of Chronic Hepatitis C Non-responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone
Lead Sponsor:
University Hospital, Geneva
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in patients who have pre...
Detailed Description
Insulin resistance and diabetes are major disease modifiers in chronic hepatitis C, as they increase liver fibrogenesis and reduce the rate of response to antivirals. Regarding the latter, a previous ...
Eligibility Criteria
Inclusion
- Histologically confirmed chronic hepatitis C as per liver biopsy performed during the 12 months prior to enrollment (except patients with histologically proven cirrhosis or a Actitest/Fibrotest assay, or a Fibroscan performed during the 12 months prior to enrollment)
- HCV RNA in serum \>600 IU/ml
- elevated ALT
- HCV genotypes 1, 2, 3 or 4
- failure to respond to a prior treatment with a pegylated interferon alpha + ribavirin
- HOMA score \> 2.00
- documentation that sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods, medroxyprogesterone acetate, surgical sterilization plus a barrier method \[diaphragm + spermicide\] or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A serum pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast feeding
- documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy
- willingness and capability to give written informed consent and to comply with the requirements of the trial
Exclusion
- history of diabetes (ADA definition)
- history of significant cardiovascular disease (NYHA III) including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure
- HBsAg and/or HIV
- auto-immune disease, including auto-immune hepatitis
- alcohol consumption exceeding 40 grams per day
- hepatocellular carcinoma
- renal insufficiency (serum creatinine levels above 200 micromol/l)
- unconjugated bilirubin blood level \> 100 micromol/l
- glutamyl transferase \> 20 times the ULN
- prothrombin time \< 60% of control (except in case of oral anti-coagulant therapy)
- neutrophil count \< 1.5 G/L
- platelet count \< 70 G/L
- hemoglobin \<120 g/L
- organ or bone marrow transplantation
- current neoplasm and/or anti-tumor chemotherapy
- current hepatic arterial thrombosis
- pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
- psychosis or anti-depressant therapy for uncontrolled clinical depression
- epilepsy
- clinically significant retinal abnormalities
- thyroid dysfunction
- drug abuse or substitution therapy during the 12 months prior to inclusion
- interstitial pneumonitis
- previous auto-immune hemolysis and all causes of chronic hemolysis
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00433069
Start Date
January 1 2007
End Date
January 1 2008
Last Update
May 28 2015
Active Locations (1)
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1
Service de Gastroentérologie et d'Hépatologie, University Hospital
Geneva, Canton of Geneva, Switzerland, 1211