Viral Kinetics in HCV Clearance in Subjects With Hemophilia
Condition: Chronic Hepatitis C; Hemophilia
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hemophilia A
Intervention: PegInterferon; Ribavirin; Telaprevir
Intervention MeSH terms: Ribavirin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; Hemophilia

Summary:

      This study will examine viral dynamic responses in subjects with chronic hepatitis C and
      hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hemophilia A or B

          2. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and
             unknown subtype)

          3. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities
             present at least 6 months prior to enrollment

          4. Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of
             enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be
             utilized during screening period. Cirrhosis is not an exclusion factor

          5. Age ≥ 18 years

          6. Prior HCV treatment naïve or experienced

          7. HCV viral load detectable during screening period

          8. Absence of exclusion criteria

          9. Sexually active subjects (both male and female) must agree and commit to the use of a
             medically acceptable form of contraception for the duration of the study and for 6
             months following the last dose of study medication. Medically acceptable forms of
             contraception include oral contraceptives, injectable or implantable methods,
             intrauterine devices or properly used barrier contraception.

        Exclusion Criteria:

          1. Hemoglobin <11

          2. Pregnancy (during screening period or any time during treatment)

               1. females, that are planning to become pregnant or are breastfeeding

               2. males, whose partner is pregnant or is planning to become pregnant

          3. HIV Infection

          4. Prior History of:

               1. Hepatitis B (HBsAG negative - must have documentation of negative results within
                  one year prior to enrollment or during screening period if not performed in that
                  time window

               2. Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level
                  <80 (at anytime prior to screening). If <80, phenotype testing should not
                  demonstrate zz phenotype. All other phenotypes are not exclusionary,

               3. History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment)
                  with evidence of iron overload requiring phlebotomy,

               4. Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody
                  (ASMA)) >1:160.

               5. Any other significant liver disease or process (to be determined by the
                  investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.

          5. History of Decompensated liver disease evidenced by any prior history of hepatic
             encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count <
             100,000

          6. Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating
             hormone (TSH); if TSH abnormal must have normal free thyroid index)

          7. Chronic renal insufficiency, defined as creatinine clearance < 50 ml/min. (estimated
             by Modification of Diet in Renal Disease (MDRD) formula)

          8. Life-threatening disease processes that could preclude completion of trial in opinion
             of investigator.

          9. Any condition which the investigator feels will preclude safe completion of the
             treatment regimen including severe psychiatric disorders, active alcohol or
             recreational drug abuse.

         10. Inability to provide informed consent.

         11. Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal
             steroids are permitted.)

         12. Uncontrolled seizure disorder (in opinion of investigator)

         13. Concurrent autoimmune processes with active disease that may be exacerbated by
             interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion
             of the investigator. Psoriasis permitted if controlled with topical medications at the
             time of study enrollment.

         14. Use of prohibited medications (as described in the telaprevir package insert) within
             14 days of the first dose of study medications