AzTrials
AzTrials

Hepatitis CPhase 2NCT00892697

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

A Phase 2 study testing Telaprevir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Weill Medical College of Cornell University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
Telaprevir, Peginterferon alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
May 2009to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects, 18-65 years of age, inclusive.
  • Cases will be genotype 1 (confirmed by standard testing). Enrollment of controls will not be restricted by genotype.
  • 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
  • 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.
  • 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.
Show all 18Show fewer
  • 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.
  • 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.
  • Female subjects must have a negative pregnancy test at all visits (screening and predose Day 1) before the first dose of study drugs.
  • Willing to refrain from the concomitant use of any medications, substances or foods.
  • Able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study requirements and restrictions.

Who cannot join

  • Received more than 4 weeks of any approved or investigational drug or drug regimen for the treatment of hepatitis C.
  • Any medical contraindications to Peg-IFN alpa-2a or RBV therapy, including any of the following:
  • Abnormal thyroid stimulating hormone (TSH) levels or poorly controlled thyroid function
  • Evidence of clinically significant cardiac dysfunction;
  • History of psychiatric disorders determined by the investigator to contraindicate the use of IFN-based therapy;
  • Antinuclear antibody (ANA) titer 1:320;
Show all 18Show fewer
  • History of hemoglobinopathies.
  • Patients coinfected with either human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
  • Decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices.
  • Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein (AFP) during screening must be less than 100 ng/mL.
  • 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.
  • Has taken any of the prohibited medications within 28 days of initiation of therapy.
  • 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.
  • Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
  • 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).
  • For cases, hypersensitivity to tartrazine (known as yellow dye #5).
  • Men whose female partners are pregnant

About this study

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

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.

Conditions
Hepatitis C
Being tested
Telaprevir, Peginterferon alfa-2a, Ribavirin
Keywords
hepatitis C, FNA, intrahepatic
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaprevirDrug

    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).

  • Peginterferon alfa-2aDrug

    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).

  • RibavirinDrug

    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).

Study groups in NCT00892697
Study groupRoleWhat they receive
ArmExperimental15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
Receives: Drug: Telaprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intrahepatic and Plasma HCV Viral Kinetics

    Intrahepatic viral kinetics, plasma viral kinetics,

    Measured: Day-7, Day 1, Day 4,

Secondary outcomes (1)

  1. Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir

    Intrahepatic and plasma telaprevir concentration ratios

    Measured: Day 1, Day 4, Day 15, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00892697
Sponsor's protocol ID
0810010040
Status last verified
Dec 2014
First submitted
30 Apr 2009
Last updated
20 Mar 2015
Data monitoring committee
Yes

Publications

  • Talal AH, Dimova RB, Zhang EZ, Jiang M, Penney MS, Sullivan JC, Botfield MC, Chakilam A, Sawant R, Cervini CM, Zeremski M, Jacobson IM, Kwong AD. Telaprevir-based treatment effects on hepatitis C virus in liver and blood. Hepatology. 2014 Dec;60(6):1826-37. doi: 10.1002/hep.27202. Epub 2014 Jul 31.

    PubMed 24811404

  • Zeremski M, Dimova RB, Benjamin S, Penney MS, Botfield MC, Talal AH. Intrahepatic and Peripheral CXCL10 Expression in Hepatitis C Virus-Infected Patients Treated With Telaprevir, Pegylated Interferon, and Ribavirin. J Infect Dis. 2015 Jun 1;211(11):1795-9. doi: 10.1093/infdis/jiu807. Epub 2014 Dec 15.

    PubMed 25512630

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaprevir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Weill Medical College of Cornell University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrahepatic and Plasma HCV Viral Kinetics (time frame: Day-7, Day 1, Day 4,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00892697, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in