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

March 9, 2015 updated by: Weill Medical College of Cornell University

#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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm
15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
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).
Drug: Peginterferon alfa-2a
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).
Drug: Ribavirin
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrahepatic and Plasma HCV Viral Kinetics
Time Frame: Day-7, Day 1, Day 4,
Intrahepatic viral kinetics, plasma viral kinetics,
Day-7, Day 1, Day 4,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir
Time Frame: Day 1, Day 4, Day 15, Week 8
Intrahepatic and plasma telaprevir concentration ratios
Day 1, Day 4, Day 15, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

  • Principal Investigator: Andrew H. Talal, MD, MPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0810010040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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