Clinical trial NCT00433069 (phase 2, status: completed)
Conditions: chronic hepatitis c
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: pioglitazone, interferon alfa-2a, ribavirin
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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