Clinical trial NCT00882193 (early phase 1, status: terminated)
Conditions: chronic hepatitis c, genotype 1, relapse
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4, C90.02, C90.22, C90.32, C92.32, C95.92, C90.12, C91.02
Drugs: betaine, peginterferon alpha 2a, ribavirin
SMILES: C[N+](C)(C)CC([O-])=O, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Reason stopped: 
    new medications with improved response released, nonaccrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be willing to give informed consent and be able to adhere to dose and
             visit schedules.

          -  History of chronic hepatitis C, genotype 1, non-responders or relapsers as documented
             by genotype testing and HCV RNA levels at 12 weeks ( < 2 log change) during therapy or
             at 3 - 12 months post therapy, respectively.

          -  Adult subjects 18-70 years of age, of either gender

          -  Liver biopsy within 3 years prior to the screening 1 visit with a pathology report
             confirming that the histological diagnosis is consistent with chronic hepatitis C.

          -  Compensated liver disease with the following maximum hematologic, biochemical and
             serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin > 12
             g/dl for females and >13 g/dl for males, WBC > 3000/mm3, Platelets > 80,000/mm3,
             Direct Bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine -
             WNL.

          -  Fasting glucose should be 70 -140 mg/dl, results between 116-140 require a HbA1c <
             8.5%

          -  TSH - WNL

          -  Subjects with a history of mild depression may be considered for entry in to this
             study provided that a pretreatment assessment of the subject's affective status
             supports that the subject is clinically stable.

          -  Subjects with a history of substance abuse must have abstained from using the
             substance for at least one year prior to the Screening visit.

          -  Antinuclear antibodies (ANA) < 1:320

          -  No radiologic evidence of a focal mass suggestive of hepatoma and/or ascites.

        Exclusion Criteria:

          -  Pregnant or nursing subjects. Subjects who intend to become pregnant during the study
             period. Subjects with partners who intend to become pregnant during the study period.

          -  Prior response to therapy and failure to achieve SVR which may have been due to
             treatment non-compliance, in the assessment of the investigator based upon subject's
             medical history.

          -  Participation in any clinical trial of a HCV protease inhibitor of any duration.
             Subjects may have received other investigational agents for the treatment of HCV, as
             long as they have also received an adequate course of Peg-IFN/RBV [i.e., the
             investigational agent could not have replaced either Peg-IFN (such as Albuferon) or
             RBV (viramidine)].

          -  History of new hepatitis C exposure within the last 6 months

          -  Current or intended use of G-CSF and/or GM-CSF during the stud period is prohibited.
             Current use of erythropoietin (EPO) is prohibited.

          -  Suspected hypersensitivity to any interferon product or ribavirin

          -  Participation in any other clinical trial within 30 days of Screening visit 1

          -  Treatment with any investigational drug within 30 days of Screening visit 1.

          -  Any other cause for liver disease other than CHC, including but not limited to:
             hemachromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Autoimmune
             hepatitis, Alcoholic liver disease, Non-alcoholic steatohepatitis (NASH), Drug-related
             liver disease

          -  Known coagulopathies including hemophilia

          -  Known hemoglobinopathies

          -  Known G6PD deficiency

          -  Known coinfection with HIV and/or HBV

          -  Evidence of active or suspected malignancy or a history of malignancy within the last
             five years (with the exception of adequately treated basal cell carcinoma of the
             skin).

          -  Evidence of decompensated liver disease such as history or presence of ascites,
             bleeding varices or hepatic encephalopathy

          -  Subjects with organ transplants other than cornea or hair transplant

          -  Any Known preexisting medical condition, that could interfere with the subject's
             participation in and completion of the study including, but not limited to moderate to
             severe depression, or a history of severe psychiatric disorder, such as psychosis,
             suicidal ideation and/or suicidal attempt; Subjects with a past history or current use
             of lithium and/or antipsychotic drugs; CNS trauma or seizure disorder; Clinically
             significant ECG abnormalities and/or significant cardiovascular dysfunction within the
             past 2 years prior to Screening ; Poorly controlled diabetes mellitis; Chronic
             pulmonary disease (COPD); Immunologically mediated disease such as inflammatory bowel
             disease, rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus
             erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis or
             symptomatic thyroid disorder; Any medical condition requiring, or likely to require
             during the course of the study, chronic systemic administration of steroids: History
             of, or active clinical gout.

          -  Substance abuse, such as alcohol (>80 g/day), IV drugs and inhaled drugs. Subjects
             with a history of substance abuse must have abstained from the abuse substance for at
             least one year. Subjects with clinically significant retinal abnormalities

          -  Any other condition which in the opinion of the investigator would make the subject
             unsuitable for enrollment, or could interfere with the subject participating in and
             completing the protocol

          -  Subjects who are part of the staff personnel directly involved with the study

          -  Subjects who are immediate family members of the investigational study staff