Clinical trial NCT00277758 (phase 1, status: terminated)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: ribavirin, ribavirin + pegylated interferon-alpha
SMILES: 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: 
    insufficient rate of volunteer accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, age >18 years to < 65 years.

          -  Ability and willingness to sign an informed consent.

          -  Hepatitis C antibody positive status confirmed by the NYPH laboratory.

          -  Genotype 1 HCV confirmed by the NYPH laboratory using the DupliType assay as performed
             by Quest Diagnostics.

          -  Liver biopsy demonstrating chronic hepatitis but without cirrhosis within 2 years of
             enrollment.

          -  Prothrombin time < 3 seconds longer than control.

          -  Platelet count ≥75,000 mm3

          -  Neutrophil count ≥ 1000/mm3

          -  Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men

          -  Subject must agree not to participate in a conception process (defined as active
             attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization
             etc.) while on study drugs and for 6 months following permanent discontinuation of
             study therapy.

        Women of reproductive potential (defined for this study as sexually mature women who have
        not been post-menopausal for at least 24 consecutive months, or have not undergone
        hysterectomy or oophorectomy) must have a negative serum or urine pregnancy test with a
        sensitivity of at least 50 MIU/mL performed within 30 days prior to enrollment and again
        within 24 hours before initiating study therapy.

        All subjects must not participate in a conception process, and if participating in sexual
        activity that could lead to pregnancy, male subjects must take every precaution to avoid
        risk of pregnancy for their female partners, women subjects/male partners must use two
        reliable methods of contraception simultaneously, while receiving study therapy and for 6
        months following permanent discontinuation of study therapy.

        NOTE A: Reliable forms of contraception are a combination of two of the following methods:
        1) condoms (male or female) with or without a spermicidal agent. 2) diaphragm or cervical
        cap with spermicide, 3) IUD, or 4) hormonal-based contraception.

        NOTE B: An IUD is an adequate method of contraception but increases the risk of pelvic
        inflammatory disease.

        Exclusion Criteria:

          -  Previous IFN-alpha, RBV or IL2 therapy

          -  Any active viral hepatitis other than hepatitis C virus infection, as defined by the
             presence of IgM antibody to Hepatitis A Virus (HAV) within 30 days of enrollment, or
             Hepatitis B Virus Surface Antigen (HBsAg) positivity, or positive plasma HBV DNA by
             PCR methodology when HB core antibody is the only serologic marker of HBV infection
             within 30 days of entry.

          -  ALT and AST > 5x ULN, total bilirubin > 1.5 x ULN

          -  Signs/symptoms of advanced liver disease.

          -  Uncontrolled infection, except hepatitis C

          -  HIV infection as determined by HIV ELISA & Western blot assay, and confirmed by plasma
             HIV assay (PCR or bDNA)

          -  Cardiac condition that cannot be controlled by medication: Because of the risk of
             anemia associated with RBV use and the potential to induce cardiac ischemia, subjects
             with a positive cardiac stress test are ineligible. Therefore, subjects > 40 years of
             age with ≥ 1 risk factor for ASHD (i.e., hyperlipidemia, hypertension, smoking
             history, family history) should have an EKG preformed. If the EKG is abnormal and
             consistent with ischemic heart disease, the subject should have a cardiac stress test
             to R/O ASHD.

          -  CNS or psychiatric illness uncontrolled by medication. In particular, psychiatric
             illness, especially depression. Subjects with a psychiatric illness, a previous
             suicide attempt or hospitalization for a psychiatric Dx Will be enrolled at the
             discretion of the investigator.

          -  Concurrent therapy with any immune-modulating agents, e.g,. interleukins, interferons,
             therapeutic vaccines, corticosteroids, immunosuppressive agents (azathioprine,
             6-mercaptopurine, Cyclosporine-A, FK506, Rapamycin, antilymphocyte antibodies).

          -  Pregnant or nursing women (all women of child bearing age should be using effective
             contraception)

          -  History of malignancy with receipt of cancer therapy within 24 weeks.

          -  Any severe illness that would make the subject unsuitable for the study.

          -  Active asthma, or asthma uncontrolled by medication.

          -  Any immunologically mediated disease, including Crohn's disease, ulcerative colitis,
             rheumatoid arthritis, lupus erythematosis, ITP, autoimmune hemolytic anemia, eczema,
             psoriasis.

          -  Untreated thyroid disease.

          -  Heroin or cocaine use within 9 months of enrollment.

          -  Inadequate venous access.

        NOTE: If screening TSH is abnormal, obtain free thyroxin index. If the free thyroxine index
        is normal, the subject may enter the study. If the free thyroxin index is low, the subject
        may be treated with thyroid hormone replacement medication and enter the study once the
        free thyroxin index is corrected. If the free thyroxin index is elevated indicating
        hyperthyroidism, the subject should not enroll in the study.

        Patients with preexistent antibodies against thyroid peroxidase or thyroglobulin should not
        be enrolled.

          -  Allergy to any of the medications to be used in the study (i.e., IL2, PEG-IFN/RBV), or
             other components of the study products. Peg Intron: benzyl alcohol, NaCl,
             Na-phosphate, EDTA, polysorbate 80, m-cresol, IL2; phosphate buffer, SDS, mannitol.
             RBV: cellulose, lactose, croscarmellose, magnesium stearate, Blue pharmaceutical ink:
             shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene
             glycol, ammonium hydroxide, Blue # 2 aluminum lake.

          -  Alcohol dependency, for example, current alcohol use of more than 1 drink/day any time
             during the previous 6 months. One drink is defined as 12 ounces of beer, 5 ounces of
             wine, or 1-¼ ounces of hard liquor.

          -  Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration

          -  Acute therapy for a serious infection or other serious medical illness that is
             potentially life threatening and requires systemic therapy and/or hospitalization
             within 14 days of study entry.

          -  Serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min as estimated by the
             Cockcroft-Gault equation. This screening value must be obtained within 30 days of
             enrollment.

          -  History of major organ transplantation with an existing graft.

          -  Subject judged by the investigator to be at significant risk of failing to comply with
             the provisions of the protocol as to cause harm to self or seriously interfere with
             the validity of the study results.

          -  Subjects with biopsy proven liver disease other than HCV infection.

          -  Subjects with hemoglobinopathies or any other causes or tendencies toward hemolysis.

          -  Subjects with chronic pulmonary disease with functional limitations.