Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00892697
First received: April 30, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin.

Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: #0810010040: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus Infection: A Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Intrahepatic and plasma HCV viral kinetics in subjects treated with telaprevir, pegylated interferon and ribavirin [ Time Frame: Day-7, Day 1, Day 4, Day 15, Week 12, Week 16, Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intrahepatic and peripheral pharmacokinetic assessment of telaprevir [ Time Frame: Day-7, Day 1, Day 4, Day 15, Week 12, Week 16, Week 48 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm
15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.
Drug: Telaprevir
Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, 18-65 years of age, inclusive.
  2. Cases will be genotype 1 (confirmed by standard testing). Enrollment of controls will not be restricted by genotype.
  3. All patients must show evidence of chronic hepatitis C, confirmed by detectable plasma HCV RNA. Chronic disease status must be confirmed by at least one of the following standard criteria:

    History of a remote risk factor, or Abnormal ALT levels for >6 months prior to screening period (Note: elevated ALT is not an inclusion criteria, if one of the other criteria for "chronic" hepatitis C is met), or Detectable HCV RNA for at least 6 months before the screening period

  4. Liver biopsy obtained within 24 months of study enrollment demonstrating absence of cirrhosis (stage 0-3) for cases. Enrollment of controls will not be restricted by stage of fibrosis.
  5. Judged to be in good health on the basis of medical history and physical examination (including vital signs and ECG), with any chronic medical conditions under stable medical control.
  6. Screening Visit laboratory values must be within the following:

    • Laboratory variable: acceptable range
    • Absolute neutrophil count: 1200/cmm³
    • Platelet count: 90,000/cmm³
    • Hemoglobin: within normal range
    • HbsAg (screening visit only): seronegative
    • HIV1 and 2 Ab (screening visit only): seronegative

    In addition, all other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.

  7. Subjects (or their female partners) must be not pregnant, planning to become pregnant within the next 72 weeks, or they must be permanently sterile or otherwise of non childbearing potential. They must also not be breastfeeding. If of child-bearing potential, subjects must agree to use 2 effective methods of contraception from screening through 6 months after the last dose of RBV. Male subjects who have a female partner of childbearing potential must agree to use 2 effective methods of contraception from Screening through 7 months after the last dose of RBV unless vasectomized.
  8. Female subjects must have a negative pregnancy test at all visits (screening and predose Day 1) before the first dose of study drugs.
  9. Willing to refrain from the concomitant use of any medications, substances or foods.
  10. Able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study requirements and restrictions.

Exclusion Criteria:

  1. Received more than 4 weeks of any approved or investigational drug or drug regimen for the treatment of hepatitis C.
  2. Any medical contraindications to Peg-IFN alpa-2a or RBV therapy, including any of the following:

    1. Abnormal thyroid stimulating hormone (TSH) levels or poorly controlled thyroid function
    2. Evidence of clinically significant cardiac dysfunction;
    3. History of psychiatric disorders determined by the investigator to contraindicate the use of IFN-based therapy;
    4. Antinuclear antibody (ANA) titer 1:320;
    5. History of hemoglobinopathies.
  3. Patients coinfected with either human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
  4. Decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices.
  5. Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein (AFP) during screening must be less than 100 ng/mL.
  6. For cases, histologic evidence of hepatic cirrhosis on any liver biopsy

    o Most recent liver biopsy must be within 2 years prior to study screening.

  7. Has taken any of the prohibited medications within 28 days of initiation of therapy.
  8. A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to a history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant illness, or history of mental illness that may affect compliance with study requirements.
  9. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
  10. Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
  11. For cases, hypersensitivity to tartrazine (known as yellow dye #5).
  12. Men whose female partners are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892697

Sponsors and Collaborators
Weill Medical College of Cornell University
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: Andrew H. Talal, MD, MPH Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00892697     History of Changes
Other Study ID Numbers: 0810010040
Study First Received: April 30, 2009
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
hepatitis C
FNA
intrahepatic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 22, 2014